Double-blind Controlled Study Research Articles

Effect of Preoperative Oral Carbohydrate Loading on Perioperative Hemodynamic in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Study

Background: Conventional preoperative fasting is associated with intravascular volume contraction, increased stress, hyperglycaemia in the perioperative period. Recently, the concept of preoperative carbohydrate loading is introduced. This study was conducted to reveal the relation between use of carbohydrate-rich fluid and perioperative hemodynamic, perfusion index, and glucose control of the patients, who were undergoing elective laparoscopic cholecystectomy under general anesthesia. Methods: This study is a double-blinded prospective randomized control study. The patients, who met the inclusion criteria were randomly divided into 2 groups of 43 each with the help of computer-generated randomization method. Patients who received preoperative carbohydrate loading and patients who follow conventional preoperative fasting for surgery were labelled as Group E and Group S respectively. Incidence of hypotension was the primary outcome; variation in blood pressure, heart rate, perfusion index, and blood glucose level were the secondary outcomes. Results: Intraoperative hypotensive episodes were significantly lower in the carbohydrate loading group in comparison to the conventional fasting group, p=0.023. The systolic, diastolic blood pressure and perfusion index were significantly lower in the conventional fasting group. Also, the heart rate was significantly higher in the conventional fasting group. Numeric rating scale, the score for pain taken at 1 hour postoperatively was significantly lower in the carbohydrate loading group. Blood glucose level postoperatively after 24 hours was significantly more in the conventional fasting group. Conclusion: The carbohydrate loading group has better hemodynamic stability and optimal intravascular volume after induction and intraoperatively. Also, the carbohydrate loading group had better glycaemic control and better pain relief postoperatively.

Impact on Psychomotor Functions by Sedative Agents Used During Daycare Surgeries: A Randomized Controlled DoubleBlinded Study of Dexmedetomidine Versus Midazolam Fentanyl

Background: Sedative agents are used during surgeries to reduce stress and anxiety and discomfort of the patient. An ideal sedation agent should provide a rapid onset of action and faster recovery. Almost all commonly used sedative agents in daycare surgeries affect the cognitive and psychomotor functions. The research question of this study was to find out which of the commonly used sedative agents- Dexmedetomidine or Midazolam-Fentanyl combination produces less impact on the psychomotor functions of the patients. Materials and Methods: Seventy two patients who were undergoing tympanoplasty under local anesthesia, were randomly divided into two equal groups - Group D (dexmedetomidine) and Group MF (midazolam and fentanyl) using a computer-based randomization scheme. Group D received dexmedetomidine till an adequate sedation score was achieved (Ramsay sedation scale =3). Group MF patients received midazolam and fentanyl till an adequate sedation score was achieved. Baseline psychomotor assessment and delirium assessment was done 30 minutes prior to the shifting of the patient to operation theatre. All the scores were compared at 30 minutes, 1 hour, 2 hours, 4 hours and 8 hours by using MMSE test and stroop color word interference test for psychomotor assessment and short-CAM & Short-CAM severity test for delirium assessment. Statistical analysis was done by applying paired t-test and repeated measure ANOVA for intra-group comparison and for intergroup comparison, independent t-test was applied. Results: There was a significant decline in MMSE score and stroop color word interference score at post-operative period as compared to the baseline values in both the groups up to 4 hours. No such significant difference was seen at 8 hours post-operative period. In both groups, more patients in MF group had mild cognitive dysfunction at 1 hour post-op period, as compared to patient in D group. None of the patients showed severe cognitive impairment. In Group MF, the total number of patients showing signs of delirium was more as compared to group D at Post-op 1 hour. But no signs of delirium were found in any patient in later readings. When presented, the severity of delirium was assessed by Short CAM severity test score. It was observed that all patients who had delirium had CAM severity score of 1 only. Conclusion: The present study concluded that drug dexmedetomidine causes less cognitive decline and less chances of producing post-op delirium as compared to midazolam-fentanyl combination when used for sedation at the time of surgery.

41385 Investigating efficacy of PDE-4 inhibitors in reducing topical steroid use for management of pediatric atopic dermatitis: A double-blind randomized control study

41385 Investigating efficacy of PDE-4 inhibitors in reducing topical steroid use for management of pediatric atopic dermatitis: A double-blind randomized control study

Effect of Platelet Rich Plasma Therapy for Shoulder Osteoarthritis: Double Blinded Randomized Controlled Study

Abstract Background Platelet-rich plasma (PRP) is widely used in musculoskeletal conditions and orthopaedic surgery ranging from clinic-based injections for tendinopathies to intra-operative application to augment soft-tissue healing. It has been used in knee osteoarthritis, rotator cuff tears, elbow epicondylitis, anterior cruciate ligament reconstruction, shoulder impingement syndrome and various tendinopathies to date, with an expanding list of indications. While available evidence supports the use of PRP in the management of lateral epicondylitis and knee osteoarthritis, there is limited clinically significant evidence for other indications Aim of the Work This study aims to evaluate the efficacy of platelet-rich plasma as a treatment for primary and secondary shoulder osteoarthritis pain. Patients and Methods A prospective, double-blinded randomized control study in Ain Shams University Hospitals from 3 to 6 months. The patients were divided into 2 groups using computerized generated randomization. The control group received 5 ml 0.9% saline injection in the intra-articular shoulder (between glenohumeral joint). The study group received 5 ml of PRP treatment. Results The study results showed: All demographic data (age, sex, weight and BMI) and chronic diseases were insignificantly different between both groups, all medical data (chronic diseases, type of osteoarthritis, severity of symptoms, time of symptoms, radiological finding and type of treatment) were insignificantly different between both groups, NRS was significantly lower in study group compared to control group at ―2nd evaluation post injection|| and was insignificantly different between both groups at ―1st evaluation post injection||. (P < 0.05), range of movement was insignificantly different between both groups at 2nd evaluation post injection and injection related complications (inflammation and infection) were insignificantly different between both groups. Conclusion In general, efficacy was observed in treatment with PRP alone in shoulder osteoarthritis. However, patients receiving PRP treatment are less likely to experience post-injection pain and are more likely to recover faster when compared to patients receiving saline alone.

Comparitive Study between Dexamethasone versus Fentanyl as Adjuvant to Local Anesthesia in Supraclavicular Nerve Block in Upper Limb Surgery

Abstract Background Peripheral nerve block as an anesthetic technique plays an important role in modern regional anesthesia. Upper limb surgeries are mostly performed under peripheral blocks such as the brachial plexus block. Peripheral nerve blocks not only provide intra-operative anesthesia, but also extend analgesia in the post-operative period without major systemic side-effects by minimizing stress response and using minimal anesthetic drugs. Objective To evaluate the effects of adding dexamethasone and fentanyl to bupivacaine in ultrasound guided supraclavicular brachial plexus block for upper limb surgery versus bupivacaine alone. Patients and Methods After obtaining approval from the medical ethical committee in Al-Matareya Teaching Hospital, this study was conducted in Al-Matareya Teaching Hospital in cooperation with Ain Shams University. It was include patients undergoing elective upper limb surgery. A written informed consent was obtained from every patient after explaining the procedure. A randomized double-blinded controlled study is thought to be the most suitable design to achieve the study objectives. Results The present study showed that addition of dexamethasone and fentanyl to bupivacaine in ultrasound-guided supraclavicular nerve block shortened the onset times of both sensory and motor blocks and significantly prolonged their duration compared to bupivacaine olny. Conclusion In the current study, the addition of dexamethasone or fentanyl to bupivacaine for supraclavicular brachial plexus block make the onset of sensory & motor block faster and prolongation of motor and sensory block duration and prolongation of duration of analgesia more than using bupivacaine only. But onset of motor and sensory block was shorter in fentanyl group than dexamethasone group and duration of sensory and motor block more in dexamethasone rather than fentanyl.

Addition of Neostigmine and Atropine to Conventional Management of Postdural Puncture Headache in Patients Undergoing Lower Abdominal Surgeries

Abstract Background Postdural puncture headache (PDPH) is a complication of spinal anesthesia or lumbar puncture and is an unpleasant experience for the patient as well as the anesthetist. It is thought to result from meningeal traction related to low cerebrospinal fluid (CSF) pressure or cerebral vasodilation as an indirect effect of decreased CSF pressure. Neostigmine is a reversible inhibitor of the enzyme cholinesterase, which results in an increased concentration of the neurotransmitter acetylcholine. It produces cholinergic-mediated analgesia and has been used as an adjunct analgesic postoperatively. Neostigmine can pass through the choroid plexus but not the blood–brain barrier, the central effect of both neostigmine and atropine influence both CSF secretion and cerebral vascular tone which are the primary pathophysiological changes in PDPH. Objective Assess the effectiveness of postdural anesthesia with addition of Neostigmine and Atropine versus conventional postdural anesthesia. Patients and Methods A 90 patients were included in our prospective randomized controlled double-blind study that was conducted at Ain Shams University Hospitals for 4 months on patients who fulfilled the inclusion criteria: patients with ASA Grade I & II, aged from (18 to 40) years old and scheduled for cesarean section. All patients aged >18 or <40, body weight >50, ASA III, IV, patients with uncontrolled chronic diseases such as hypertension, cardiac, renal, hepatic, cerebral diseases and peripheral vascular diseases, patients with history of PDPH, chronic headache, cluster headache, migraine, convulsions, cerebrovascular accident, signs of meningismus, preeclampsia, eclampsia coagulopathy, and previous neurological diseases and patients with history of bronchial asthma were excluded. Patients were divided into 2 groups: Group I (experimental group): neostigmine and atropine and Group II (placebo group): Saline placebo. Results The results of this study showed that incidence of postoperative headache was significantly lower among the intervention group, furthermore, VAS was significantly lower in the experimental arm versus placebo one. However, there was no significant difference regarding demographic, vital signs, and need for post-operative analgesia. The presented study showed that there is statistically non-significant difference between the studied groups regarding age, weight, and height and body mass index. There is statistically non-significant difference between the studied groups regarding duration of surgery. Conclusion After demonstrating many management options for post dural puncture headache (PDPH), in this study, we tried to prove the value of the use of neostigmine as a new management option that looks promising to alleviate the symptoms of such distressing condition. The current study results proved that the drug reduced the number of cases that experienced (PDPH) after spinal anesthesia for lower segment caesarean section, and how it prevent &control headache. A combination of neostigmine and atropine are effective in managing PDPH by reducing the associated VAS score and preventing persistence of headache.

Effects of cranial electrotherapy stimulation on improving depressive symptoms in people with stress: A randomized, double-blind controlled study

BackgroundCranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers alternating microcurrent via electrodes on the head. We investigated the effectiveness of CES in reducing stress. MethodsParticipants who experienced subjective stress combined with subclinical depression or insomnia were recruited based on interviews and questionnaires. The subjects were randomly assigned to the active CES or sham groups and asked to use the device for 30 min twice a day for three weeks. Psychological rating scales, quantitative electroencephalography (QEEG), and serial salivary cortisol levels were measured before and after the intervention. ResultsSixty-two participants (58 females, mean age = 47.3 ± 8.2 years) completed the trial. After intervention, the depression scores improved significantly to a nearly normal level (Beck depression inventory-II, 31.3 ± 11.6 to 10.8 ± 7.2, p < 0.001) in the CES group, which were greater improvement compared to the sham group (p = 0.020). There were significant group-by-visit interactions in absolute delta power in the temporal area (p = 0.033), and theta (p = 0.038), beta (p = 0.048), and high beta power (p = 0.048) in the parietal area. CES led to a flattening of the cortisol slope (p = 0.011) and an increase in bedtime cortisol (p = 0.036) compared to the sham group. LimitationsBias may have been introduced during the process because device use and sample collection were self-conducted by participants at home. ConclusionsCES can alleviate depressive symptoms and stress response, showing a potential as an adjunctive therapy for stress.

Change in Negative Affective Bias following a Single Ketamine Treatment for Treatment-Resistant Depression

Ketamine has recently emerged as a highly effective new treatment for people with treatment-resistant depression with rapid antidepressant effects. However, these effects are often short lasting, and the potential cognitive mechanisms underlying the therapeutic effects, such as effects on emotional processing bias, remain poorly understood. In the present study, we explored potential changes in emotional and cognitive processing following a single treatment of subcutaneous ketamine in a randomised double-blind controlled study with an active control. Participants with treatment-resistant major depressive disorder (MDD) were recruited from a single site from the Ketamine for Adult Depression Study (KADS Trial) and were randomly assigned to receive racemic ketamine hydrochloride ( n = 10 ) or midazolam hydrochloride ( n = 11 ) in a 1 : 1 ratio. A healthy control sample ( n = 23 ) was recruited to attend a single experimental session without any treatment. All MDD participants completed mood ratings and cognitive assessments prior to and one day after a single randomised treatment. The results showed no significant differences in performance changes after treatment across the majority of emotion-related (i.e., Emotional Stroop Task, Affective Go/No-Go Task) and cognitive (Ruff 2 and 7 Selective Attention Test, Controlled Word Association Test) outcome measures. Participants who received ketamine showed a significant improvement in a negative processing bias test (i.e., The Scrambled Sentence Task; Cohen’s d = .67 , p = .016 ), which was not significantly associated with improvement in psychological symptoms ( r = − .662 , p = .074 ). The results from this exploratory study suggest that a single ketamine treatment may modulate negative affective bias. Limitations to this study included the small sample size and lack of follow-up. Future larger trials are required to confirm this finding.

The influence of radio frequency-based toothbrush on the accumulation of calculus and periodontal health: A randomized double-blind controlled prospective study.

The use of a toothbrush with radio frequency (RF) has shown to be of benefit regarding the reduction of plaque, calculus, and dental staining and improving teeth shade compared to conventional powered and manual toothbrushes. To evaluate the efficacy of the RF toothbrush in the reduction of calculus accumulationand its effect on periodontal parameters as well as subject satisfaction as compared to an identical sham-tooth brush. Patients who are under a strict maintenance program were included. Patients were allocated to test (RF toothbrush) or control (sham) randomly and were examined at baseline, one and three months. Clinical photos were taken and a consequential calculus assessment via ImageJ software. Clinical assessment included the following: plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), and recession (REC). Patient satisfaction was assessed via a questionnaire. Fifty-eight patients (29 control, 29 test) were included. At baseline mean PPD, BOP, PI, REC, and calculus accumulation were similar between the groups. Mean buccal calculus was lower in the test group at one month 4.0% versus 6.7%, p < .05. Calculus accumulation within the groups was lower in the test group at 1 and 3 months when compared to baseline at the buccal aspect (2.8% vs. 8.9%, p < .05% and 3.8% vs. 8.9%, p < .05) and lingual aspect (6.7% vs. 16.5%, p < .05% and 8.9% vs. 16.5%, p < .05). No statistically significant results were found regarding periodontal parameters PPD, BOP, PI, and REC. No difference was found between groups regarding patient satisfaction. RF seems to have an additive effect on preventing calculus accumulation on the buccal aspect of anterior mandibular teeth at 1 month. Nevertheless, at 3 months, no difference between the toothbrushes is seen regarding calculus formation and maintaining periodontal health (ClinicalTrials.gov, Identifier NCT04640857).

Hen egg white bovine colostrum supplement reduces symptoms of mild/moderate COVID-19: a randomized control trial.

The ability of a hen egg white bovine colostrum supplement to prevent severe COVID-19 was tested in a double-blind randomized control study. Adults with mild/moderate COVID-19, risk factors for severe disease, and within 5days of symptom onset were assigned to the intervention (n=77) or placebo (n=79) arms. Symptoms were documented until day 42 post-enrollment and viral clearance was assessed at 11-13days post-symptom onset. One participant developed severe COVID-19. The severe-type symptom score was lower in the active arm at 11-13days post-symptom onset (p=0.049). Chest pain, fever/chills, joint pain/malaise, and sore throat were significantly less frequent in the active arm. No differences in viral clearance were observed. The intervention reduced symptoms of mild/moderate COVID-19. DOH-27-062021-9191 (South African National Clinical Trials Register).

Perioperative Intravenous Nefopam on Pain Management and Ambulation after Open Spine Surgery: A Randomized Double-Blind Controlled Study.

This was a randomized double-blind controlled study. This study was designed to evaluate the effects of intravenous nefopam regarding its ability to reduce morphine consumption and postoperative pain and improve recovery in patients undergoing open spine surgery. Multimodal analgesia, including nonopioid medications, is essential for pain management in spine surgery. Evidence regarding the use of intravenous nefopam in open spine surgery as part of enhanced recovery after surgery is lacking. In this study, 100 patients undergoing lumbar decompressive laminectomy with fusion were randomized into two groups. The nefopam group received 20-mg intravenous nefopam diluted in 100-mL normal saline intraoperatively, followed by 80-mg nefopam diluted in 500-mL normal saline, administered as a continuous infusion postoperatively for 24 hours. The control group received an identical volume of normal saline. Postoperative pain was managed using intravenous morphine via patient-controlled analgesia. Morphine consumption in the first 24 hours was recorded as the primary outcome. Secondary outcomes, including postoperative pain score, postoperative function, and length of hospital stay (LOS), were assessed. No statistically significant differences in the total morphine consumption and postoperative pain score in the first 24 hours postoperatively between the two groups. At the post-anesthesia care unit (PACU), the nefopam group demonstrated lower pain scores while at rest (p =0.03) and upon movement (p =0.02) than the normal saline group. However, the severity of postoperative pain between the two groups was similar from postoperative day 1 to day 3. LOS was significantly shorter in the nefopam group than in the control group (p <0.01). The time to first sitting and walking and PACU discharge between the two groups were comparable. Perioperative intravenous nefopam demonstrated significant pain reduction during the early postoperative period and shortened LOS. Nefopam is considered safe and effective as a part of multimodal analgesia in open spine surgery.

Looking Back to Move Forward: The Current State of Research on the Clinical Applications of Camphor- and Menthol-Containing Agents.

Topically appliedcompounds containing camphor and mentholhave been used to alleviate pain, cold symptoms, and pruritus, historically predominantlyin East Asia. Being not studied well, they are less recognized in Western medicine. Given the commonality of pain, pruritus, and cold symptoms in addition to the growing need for non-opioid treatment options, the authors investigated clinical applications of such compounds for their over-counter usage. The purpose was to analyze current clinical research and applications regarding the use of these topical agents. This study involved a bibliometric analysis of peer-reviewed articles, published in English and indexed in PubMed from 2010 to 2022, pertaining to camphor- and menthol-containingcompounds. There were 103 results, of which 15 (14.6%) articles were related to the treatment of disorders related to health, such as upper respiratory infection, pain, and pruritus. Excluded were "non-research" articles (e.g., letters to the editor), articles that do not involve human subjects, reports of improper application or misuse (e.g., ingestion), and articles pertaining to intraoral, intranasal, and ophthalmic agents. Of these articles, the originating journals, respective journal impact factor scores, publication years, study designs, and study topics were identified. Underlying trends and themes regarding clinically relevant research on these compounds were subsequently discerned. Based on this analysis, topical agentscontaining camphor and mentholare potentially effective at treating pain, upper respiratory infection symptoms, and pruritus in addition to potentially functioning as an antimicrobial. However, with a limited number of studies addressing these compounds' uses in each application, no definitive recommendation can be made regarding their use. Given the promising results of earlier studies, the authors recommend that more primary research, particularly randomized, double-blind controlled studies, be done regarding clinical applications of thesesubstances.

Postoperative analgesic effect of hyaluronidase versus dexamethasone as additives to bupivacaine in transversus abdominis plane block for inguinal hernia repair: prospective, randomized, and double-blinded controlled study

Background Inguinal hernia repair is associated with severe postoperative pain. Transversus abdominus plain block has been proved to provide effective analgesia for somatic lower abdominal pain. Several adjuvants have been added to local anesthetic to improve the quality of analgesia. This study compares the additive effect of hyaluronidase versus dexamethasone to improve the quality of analgesia of transversus abdominus plain block for inguinal hernia repair. Patients and methods This prospective, randomized, controlled, and double-blind study was carried out in Sohag University Hospital between November 2020 and February 2021. Seventy-five participants scheduled for inguinal hernia repair were included and randomly assigned into control, hyaluronidase, and dexamethasone groups. Exclusion criteria were neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal, hepatic disease, alcoholism or drug abuse, pregnancy or lactating women, and patients receiving adrenoceptor agonist or antagonist therapy or chronic analgesic therapy, patients with morbid obesity, coagulopathy, and known allergy to study medications, and sepsis surgical scar at the site to be operated upon and those who refuse. We targeted from this study to assess time to first analgesia, consumption of morphine, and visual analog scale at rest and during physical activity. Also, we targeted to assess heart rate, noninvasive blood pressure, SpO2%, and adverse effects (nausea and vomiting, respiratory depression). Results Our study showed comparable analgesic efficacy for hyaluronidase versus dexamethasone with longer time to the first request of analgesia, less morphine consumption, and less side effects compared with these two groups to the control group. Conclusion Adding hyaluronidase or dexamethasone to bupivacaine not only prolonged the duration of analgesia and decreased the consumption of opioids but also decreased the incidence of adverse effects.

Efficacy of Oral Dextrose versus Acetaminophen versus Placebo on Pain Relief during Retinopathy of Prematurity Eye Examinations: A Randomized, Double-Blind Controlled Clinical Trial.

To assess the effect of oral dextrose versus acetaminophen versus placebo in pain relief in retinopathy of prematurity (ROP) examination. In this prospective randomized, double-blind controlled clinical trial study performed in the ophthalmology clinic of Shafa Hospital (referral hospital for eye disease), Kerman, Iran, 105 premature neonates with birth weight ≤2000 g and gestational age between 28 and 34 weeks were studied. Pain score measurement with Premature Infant Pain Profile-Revised (PIPP-R) during ROP examination in three intervention groups, acetaminophen group (15 mg/kg oral acetaminophen), dextrose group (one cc of oral dextrose 50%), and placebo group (one cc of distilled water), was done. Out of 105 infants, 33 infants received acetaminophen drops, 35 infants received dextrose drops, and 37 infants received placebo. The mean pain score of the group receiving acetaminophen was 11.39, dextrose 12.17, and placebo 11.54. The acetaminophen group had a lower average PIPP-R score. This difference was not significant between the three groups (P = 0.38). Acetaminophen and dextrose in comparison with distilled water did not show a significant difference in reducing neonatal pain during ROP examinations. However, the PIPP-R score in the acetaminophen group was lower compared to the other groups.

DS11 A double-blinded randomized control study to compare the effectiveness and safety of intralesional vitamin D3 with intralesional triamcinolone and its correlation with tissue expression of vitamin D receptors in patients with keloid

Abstract Intralesional steroids are the first line of treatment for keloids, and intralesional vitamin D has shown promise in the management of keloids in a few small studies. The aim was to compare the efficacy and safety of intralesional vitamin D with intralesional triamcinolone and its correlation with tissue expression of vitamin D receptors (VDRs) in the treatment of keloids. Sixty patients were randomly divided into two groups in 1 : 1 ratio. Patients in group A received intralesional vitamin D (200 000 IU, dose 0.2 mL cm−2); those in group B received intralesional triamcinolone acetonide (20 mg mL−1, dose 0.1 mL cm−2). Four monthly injections were given, and the patients were followed-up for a further 24 weeks. The Vancouver Scar Scale (VSS) was used for keloid evaluation. Pre- and post-treatment biopsies of 20 patients from both groups were taken to assess the correlation between the expression of VDR receptor levels before and after treatment. The mean VSS scores of patients in both groups were statistically significantly reduced over the course of the follow-up (P &amp;lt; 0.001). Mean (SD) reduction in VSS at the end of treatment period was 5.17 (0.59) in patients in group A and 4.77 (0.77) in those in group B. The proportion of the patients showing &amp;gt; 50% reduction in VSS score was higher in patients in group B vs. those in group A (77% vs. 50%; P = 0.032). Rates of recurrence were comparable between the two groups (P = 0.51). Hypopigmentation (80% vs. 37%; P &amp;lt; 0.001) and atrophy (73% vs. 40%; P = 0.009) were more common in patients in group B than in those in group A. There was no significant difference in pre- and post-treatment values of tissue VDR expression in either group. Both triamcinolone and vitamin D are effective in the management of keloids. Although the reduction in VSS score was higher with corticosteroids than vitamin D, an intralesional injection of vitamin D had lower incidence of adverse effects such as atrophy and hypopigmentation.

Effects of intraoperative esketamine addition on gastrointestinal function after benign gynaecological laparoscopic surgery: a double-blind, randomized controlled study

BackgroundGastrointestinal hypokinesis can occur transiently after benign gynecologic surgery. Opioids cause the side effect of postoperative gastrointestinal hypokinesis, but an opioid-sparing anaesthetic protocol based on esketamine reduces intraoperative opioid consumption. Therefore, this study hypothesised that an opioid-sparing anaesthetic protocol based on esketamine would shorten the gastrointestinal function recovery time after benign gynaecological laparoscopic surgery.MethodsThis was a prospective randomized controlled double-blind study conducted in a single centre. All patients scheduled for elective benign laparoscopic gynaecological surgery at Xing’an Meng People’s Hospital, Inner Mongolia Autonomous Region, from November 2021 to April 2022 were consecutively enrolled and randomly divided into the opioid-sparing anaesthesia group (Group OS) and the conventional anaesthesia group (Group C). Postoperative first exhaust time, feeding time and postoperative nausea and/or vomiting (PONV) were analyzed in both groups.ResultsA total of 71 patients were enrolled in this study, including 35 in Group OS and 36 in Group C. The general condition, operative time, type of surgery, intraoperative bleeding, intraoperative fluid volume and intraoperative urine volume were not statistically different between the two groups. Compared with Group C, significantly shorter first postoperative flatus time (11 [8, 14] h vs. 14 [11, 18], p = 0.003) and anaesthesia resuscitation time (7 [6, 9] h vs. 9 [7, 11] h, p = 0.013)were observed in the OS group. The incidence of PONV in Group OS was significantly lower compared with Group C (11.4% vs. 41.7%, p = 0.007).ConclusionThe esketamine-based opioid-sparing anaesthetic protocol can shorten the postoperative first flatus time after benign laparoscopic surgery in gynaecology, and reduce the incidence of PONV. In addition, the application of esketamine may reduce the postoperative opioid dose requirement of patients.Trial registration: This study was registered with the China Clinical Trials Registry (registration number: ChiCTR2100052528, 30/10/2021).

Injections of platelet-rich plasma prepared by automatic blood cell separator combined with topical 5% minoxidil in the treatment of male androgenetic alopecia.

Platelet-rich plasma (PRP) has been increasingly accepted as a potential therapy in the treatment of androgenetic alopecia (AGA), However, there remains a dearth of data on the effectiveness of PRP prepared by automatic blood cell separator with a combination of topical minoxidil for the treatment of AGA. To evaluate the efficacy and safety of PRP prepared by automatic blood cell separator combined with topical 5% minoxidil therapy in male AGA. Thirty male patients with mild/moderate AGA were enrolled in a randomized double-blind controlled study. Patients were randomly divided into two treatment arms: (group A) PRP prepared by automatic blood cell separator combined with topical 5% minoxidil group; (group B) PRP prepared by automatic blood cell separator combined with a topical placebo group. Trichoscopic assessments regarding hair density/quantity and mean hair diameter were performed at baseline and follow-up. Clinical efficacy of global photography and patient satisfaction were conducted to verify the therapeutic efficacy of the treatment, and the occurrence of adverse reactions was recorded. We detected a significant increase in all patients in hair density and quantity after PRP treatment (p < 0.05), and there was no significant difference in mean hair diameter. Although hair density/quantity was more pronounced in group A than in group B, the difference between groups was not statistically significant (p > 0.05). In terms of clinical efficacy and patient satisfaction, group A was superior to group B, and no serious adverse reactions occurred. We hereby conclude that the injections of PRP prepared by an automated method are effective and safe in the treatment of mild-to-moderate male AGA patients, and its combination with topical 5% minoxidil therapy was superior to PRP monotherapy with better clinical efficacy and higher patient satisfaction.

Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study

MVC-COV1901 is a protein vaccine based on the same SARS-CoV-2 strain used in mRNA vaccine mRNA-1273. Data are lacking on immunogenicity and safety of MVC-COV1901 as heterologous boost for people already received one dose of mRNA-1273. This is a randomized, double-blind trial that recruited adults aged 20-70 years who previously received a single dose of mRNA-1273 vaccine and were randomly assigned in a 1:1 ratio to receive a second dose with the homologous vaccine or protein-based MVC-COV1901 8-12 weeks after the first dose. The primary outcome was neutralizing antibody titers in terms of the geometric mean titer (GMT) 14 days after the second dose. Safety was assessed in all participants who received a dose of the study vaccine. The study is registered with ClinicalTrials.gov (NCT05079633). From September 30 to November 5, 2021, 144 participants were enrolled and randomly assigned to the MVC-COV1901 boost group (n=72) or the mRNA-1273 boost group (n=72). The neutralizing antibodies on Day 15 and the anti-SARS-CoV-2 IgG titers on Day 15 and 29 of homologous mRNA-1273 were significantly higher than those of heterologous mRNA-1273/MVC-COV1901. Cellular immune responses were comparable in both groups. However, adverse events were much more frequent after the mRNA-1273 boost than after the MVC-COV1901 boost. Our results show that heterologous boost with MVC-COV1901 yielded an inferior immunogenicity but significantly fewer adverse events, compared with homologous boost with mRNA-1273. In people experienced severe adverse events after prime dose of mRNA-1273, as well as in periods when the supply of mRNA-1273 is limited, MVC-COV1901 could serve as an acceptable alternative heterologous boost.

Efficacy of different local anaesthetic volumes during erector spinae block for postoperative pain management in patients undergoing open nephrectomy operations. A randomized controlled study

ABSTRACT Background Pain control after surgery is of highest priority. Erector spinae plane block [ESPB] was reported to be a successful method to reduce pain scores and consumption of postoperative opioids. However, hardly any investigation has looked at the ideal volume of bupivacaine for ESPB. So, this work tried to fill this gap of literature in patients undergoing simple nephrectomy. Methods In this randomized double blinded control study, 100 cases undergoing simple nephrectomy were randomized into 4 groups with 25 patients per group. Group E1, 2, and 3 received ESPB with 2.5, 3.4, and 6.6 ml/segment of 0.25% bupivacaine, respectively, whereas there was no block given to the control group. Intraoperative fentanyl consumption, heart rate [HR] and the blood pressure [BP], Postoperative morphine consumption, time passed to first analgesic request, numerical rating score [NRS] of pain, the complications, HR and BP were documented for 24 hours after the operation. Results The reduction in intraoperative fentanyl consumption, postoperative morphine consumption and NRS were a significantly different between the block groups and control. Group E3 had significant difference from other groups with the longest time to first analgesia request. A lower HR was shown in block groups but within normal range. BP showed insignificant difference between groups. There were no reported complications in all study groups. Conclusions The volume of 6.6 ml/level was associated with the best pain control, without significant hemodynamic changes or adverse events as compared to other groups. This suggests that this volume may be the optimal for ESPB in patients undergoing simple nephrectomy.

Comparative Evaluation of Intranasal Dexmedetomidine Spray Versus Intranasal Normal Saline Spray in Patients Undergoing Transalveolar Extractions for Anxiety Reduction: A Randomized Control Study.

Dexmedetomidine has dose-dependent selectivity for alpha 2 adrenoceptors. It is a good sedative with analgesic characteristics and good haemodynamic stability. Intranasal sedation is a non-invasive medication delivery method that is both safe and well accepted by both children and adults. One of the most common procedures in maxillofacial surgery is transalveolar extraction. In minor oral surgery, a painless transalveolar extraction with little post-operative pain would be ideal. To examine the effectiveness of intranasal dexmedetomidine spray against intranasal normal saline spray in patients undergoing transalveolar extractions for anxiety relief. We compared sedation effect by Ramsay sedation scale, analgesia by visual analogue scale, monitored BP and pulse rate for anxiety, and spo2 levels for any complication in this prospective double-blinded randomized control study for two groups, A group with intranasal dexmedetomidine spray and the B group of intranasal NS spray for placebo effect at 0min, 15min, 30min, and 45min until transalveolar extraction. As a result of the intranasal spray of dexmedetomidine, there were no related problems such as respiratory depression. There was a substantial difference in sedation and analgesia between group A and the placebo group, as well as a significant decrease in pulse rate and hypotension in the dexmedetomidine group to reduce anxiety. Intranasal injection of atomized dexmedetomidine (1.5mcg/kg) for patient sedation having transalveolar extractions or other minor surgical operations in oral and maxillofacial surgery is clinically effective, convenient, lowers anxiety, and safe.Clinical Trial Registration: No. CTRI/2021/07/035181.