Double-blind Controlled Study Research Articles

Efficacy of ketamine in the treatment of migraines and other unspecified primary headache disorders compared to placebo and other interventions: a systematic review.

BackgroundMigraine headaches are the second leading cause of disability worldwide and are responsible for significant morbidity, reduction in the quality of life, and loss of productivity on a global scale. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of ketamine on migraines and other primary headache disorders compared to placebo and other active interventions, such as midazolam, metoclopramide/diphenhydramine, and prochlorperazine/diphenhydramine.MethodsAn electronic search of databases published up to February 2021, including Medline via PubMed, EMBASE, Web of Science, and Cochrane Library, a hand search of the bibliographies of the included studies, as well as literature and systematic reviews found through the search was conducted to identify randomized controlled trials (RCTs) investigating ketamine in the treatment of migraine/headache disorders compared to the placebo. The authors assessed the risk of bias according to the Cochrane Handbook guidelines.ResultsThe initial search strategy yielded 398 unduplicated references, which were independently assessed by three review authors. After evaluation, this number was reduced to five RCTs (two unclear risk of bias and three high risk of bias). The total number of patients in all the studies was 193. Due to the high risk of bias, small sample size, heterogeneity of the outcomes reported, and heterogeneity of the comparison groups, the quality of the evidence was very low. One RCT reported that intranasal ketamine was superior to intranasal midazolam in improving the aura attack severity, but not duration, while another reported that intranasal ketamine was not superior to metoclopramide and diphenhydramine in reducing the headache severity. In one trial, subcutaneous ketamine was superior to saline in migraine severity reduction; however, intravenous (I.V.) ketamine was inferior to I.V. prochlorperazine and diphenhydramine in another study.ConclusionFurther double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.

A randomized, double-blind controlled clinical study to evaluate the efficacy and safety of minoxidil topical 2% nanosuspension with aqueous base in the treatment of androgenetic alopecia areata

A randomized, double-blind controlled clinical study to evaluate the efficacy and safety of minoxidil topical 2% nanosuspension with aqueous base in the treatment of androgenetic alopecia areata

A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

Effect of Dexamethasone as an Adjuncton Efficacy of Ropivacaine in Caudal Block forPostoperative Analgesia in Paediatric Infra-Umbilical Surgeries: A Randomised Double-blind Controlled Study

Introduction: Caudal block is a routinely performed analgesic and anaesthetic technique in paediatric population undergoing various infra-umbilical surgeries. Various adjuvants have been used along with local anaesthetics like ropivacaine in single-shot caudal block for enhancing postoperative analgesia in paediatric infra-umbilical surgeries. Aim: To evaluate the efficacy of dexamethasone used as an adjuvant to 0.2% ropivacaine in caudal block for postoperative analgesia in paediatric patients. Materials and Methods: This was a randomised doubleblinded controlled study conducted on 80 paediatric patients (8 months-8 years), with American Society of Anesthesiologists (ASA) physical status I or II undergoing various infra-umbilical surgeries,at a tertiary care teaching institute from April 2019 to September 2019. These total subjects were randomly allocated into two groups. GroupR (n=40) administered 0.2% ropivacaine (1 mL/kg) while GroupRD (n=40) administered 0.2% ropivacaine (1 mL/kg) with dexamethasone (0.1 mg/kg) in caudal block. The duration of analgesia, postoperative pain scores (Face Legs Activity Cry Consolability (FLACC) score), rescue analgesic consumption in 24 hours, haemodynamic changes and side-effects were noted. The rescue analgesic (paracetamol 15 mg/kg oral) was given whenever FLACC ≥4. Standard qualitative and quantitative tests (unpaired student t-test, Chi-square test) were used to analyse and compare the results obtained. Results: The mean duration of analgesia was significantly longer in Group RD (745.21±146.91 min) as compared to GroupR (440.38±76.44 min); (p-value <0.001). The significantly lower FLACC pain scores were noted in patients in Group RD compared to Group R; (p-value <0.05). The rescue analgesic consumption was significantly lesser in Group RD in terms of requirement of number of doses of rescue analgesic than in Group R; (p-value <0.05). No significant haemodynamic changes or side-effects were observed in both groups; (p-value >0.05). Amongst postoperative complications noted, fever was observed in 1 patient (3.33%) and PONV in 2 patients (6.66%) in Group R. None complications were observed in the patients of RD group. Conclusion: Dexamethasone (0.1 mg/kg) was found to be safe and effective adjuvant to 0.2% ropivacaine for caudal block in children undergoing various infra-umbilical surgeries.

Comparative evaluation of efficacy and safety of drotaverine versus mebeverine in irritable bowel syndrome: A randomized double-blind controlled study

Background:Drotaverine and Mebeverine are used for alleviating the pain of IBS, but the evidence for their efficacy is scarce. In this randomised control study, we evaluated and compared their efficacy in improving severity, frequency of pain and its associated symptoms.Methods:Patients fulfilling the ROME III criteria of IBS were evaluated in this randomised control trial during 4 weeks of treatment. Group A (n = 100) received 80 mg Drotaverine and Group B (n = 100) received 135 mg Mebeverine three times a day, 1 hour before meals. Primary outcome measure was, the reduction in severity of pain (>30% reduction) assessed by VAS (0 to 10 scale) & PSS (patient symptoms scores).Results:The pain severity score fell from 6.02 to 4.8 on day 3 in Group A as compared to decrease from 6.72 to 6.62 in Group B (p < 0.01). This significant reduction in pain severity was observed till the end of the study, reducing from 6.02 to 1.78 (74% reduction) in Group A compared to 6.72 to 3.62 (46.1% reduction) in Group B (p < 0.05). There was a significant reduction in pain frequency, straining on stool, a change in one score in Bristol stool chart (BSC), achievement of complete spontaneous smooth bowel movement in Group A, compared to Group B patients. A significant improvement in Patient's evaluation of Global Assessment of Symptoms (p < 0.05) and Patient Assessment of Constipation – Quality Of Life (PAC-QOL) (p < 0.01) was observed in Group A compared to Group B.Conclusion:Drotaverine was significantly superior in efficacy as compared to Mebeverine in alleviating pain severity (starting from day 3), frequency and stools-elated symptoms of IBS.

Intravenous ondansetron to prevent hypotension during cesarean section under spinal anaesthesia

Background: Spinal anesthesia for cesarean section (CS) is associated with common side effects like hypotension and bradycardia. Ondansetron, a 5HT3 receptor antagonist, inhibits Bezold-Jarish reflex and has been found to be effective for prevention of spinal-induced hypotension for elective cesarean section. Aims: The aim of this study was to evaluate the effect of two different doses of ondansetron as prophylaxis to prevent hypotension during spinal anesthesia for caesarean section. Materials and Methods: This prospective randomized double-blinded controlled study was conducted on 150 full-term parturients undergoing CS under spinal anesthesia, who were divided into three groups, receiving saline or different drug doses: Group C: 0.9% Normal Saline 10 ml; Group O4: 4 mg Ondansetron in 8 ml NS; or Group O8: 8 mg Ondansetron in 6 ml NS, 5 min before spinal anesthesia. All the patients were monitored for blood pressure, heart rate, vasopressor requirement, and side effects. Hemodynamic variables and demographic data were compared by analysis of variance (ANOVA) and Chi-square test was used for analyzing adverse effects and P value

Aloe barbadensis Mill. extract improves symptoms in IBS patients with diarrhoea: post hoc analysis of two randomized double-blind controlled studies.

Background:Aloe barbadensis Mill. (Aloe) extract was found to be well-tolerated, safe and showed beneficial effects in subsets of irritable bowel syndrome (IBS) patients in two randomized, double-blind, controlled studies. However, the individual studies were underpowered to perform subgroup analyses. We therefore determined the effect of Aloe extract in IBS subgroups in a post hoc analysis combining the results from the two studies.Methods:Data from the two controlled studies comparing Aloe and control treatment taken orally for 4 weeks, were pooled. Both studies included IBS patients fulfilling the ROME III criteria and IBS Symptom Severity Score (IBS-SSS) was assessed. We analysed the effect of Aloe extract on IBS symptom severity and the proportion of responders (IBS-SSS reduction ⩾ 50) in IBS subgroups.Results:In total, 213 IBS patients were included in the post hoc subgroup analyses. A reduction in overall symptom severity, primarily driven by effect on pain severity and frequency, comparing baseline versus end of treatment, was recorded in IBS patients with diarrhoea (IBS-D) receiving Aloe (n = 38, p < 0.001) but not control treatment (n = 33, p = 0.33), with difference between the treatment groups (p = 0.01). Moreover, the frequency of responders was higher in IBS-D patients receiving Aloe (n = 22, 58%) compared to control treatment (n = 10, 30%) (p = 0.02). The effect of Aloe extract treatment on IBS symptom severity was not superior to control treatment in the other IBS subtypes.Conclusion:Aloe extract improves symptom severity in IBS-D patients and can be regarded as a safe and effective treatment option for this patient group.

Platelet-rich plasma for the treatment of lichen sclerosus.

Aim:Evaluate the clinical effectiveness of platelet-rich plasma as a treatment for lichen sclerosus.Methods:A systematic review was performed. The electronic databases PubMed, Ovid MEDLINE®, Web of Science, Cochrane, clinicaltrials.gov were used to identify case studies, case series, prospective uncontrolled, and randomized controlled studies published between 1946 and April 21, 2021. Six prospective uncontrolled studies, one randomized double-blind prospective study, and one case report were included.Results:Platelet-rich plasma treatment was subjectively reported to improve quality of life, but objective measures demonstrating treatment efficacy were not observed. In addition, platelet-rich plasma preparation and administration between studies lacked standardization.Conclusion:Platelet-rich plasma may be used for symptomatic adjuvant treatment of lichen sclerosus, though additional double-blind controlled studies with standardized platelet-rich plasma protocols are needed to better characterize the efficacy of platelet-rich plasma.

Systematic evaluation of Huaier Granules adjuvant treatment of primary liver cancer

To systematically evaluate the efficacy and safety of Huaier Granules in the adjuvant treatment of primary liver cancer. The databases of CNKI, Wanfang, VIP, CBMdisc, PubMed, Cochrane Library and EMbase were searched by computer to screen out the randomized controlled trial on Huaier Granules combined with Western medicine in the treatment of primary liver cancer from the establishment of the databases to January 2020. Data extraction and quality evaluation were conducted for the included literature. Meta-analysis was conducted with RevMan 5.3 software, and evidence quality evaluation was conducted for the outcomes by GRADE profiler software. A total of 24 articles were included, with a total sample size of 2 664 cases. Meta-analysis showed that as compared with Western medicine alone, Huaier Granules combined with Western medicine could improve the objective remission rate(RR=1.38, 95%CI[1.26, 1.51], P&lt;0.000 01), disease control rate(RR=1.29, 95%CI[1.10, 1.52], P=0.002) and 6-month survival rate(RR=1.20, 95%CI[1.10, 1.32], P&lt;0.000 1), 1-year survival rate(RR=1.39, 95%CI[1.23, 1.58], P&lt;0.000 01), 2-year survival rate(RR=1.95, 95%CI[1.28, 2.96], P=0.002), KPS score(MD=17.15, 95%CI[6.47, 27.83], P=0.002) and the improvement rate of KPS score(RR=2.02, 95%CI[1.47, 2.77], P&lt;0.000 1), AFP decline rate(RR=1.40, 95%CI[1.20, 1.62], P&lt;0.000 1), CD3~+(MD=17.34, 95%CI[9.28, 25.40], P&lt;0.000 1), CD4~+(MD=8.62, 95%CI[1.59, 15.64], P=0.02), CD8~+(MD=1.95, 95%CI[-3.93, 7.82], P=0.52), CD4~+/CD8~+(MD=0.42, 95%CI[-0.33, 1.17], P=0.27); reduce the level of AFP(MD=-71.57, 95%CI[-80.42,-62.72], P&lt;0.000 01), recurrence rate(RR=0.76, 95%CI[0.67, 0.85], P&lt;0.000 01), and incidence of adverse reactions(RR=0.60, 95%CI[0.41, 0.89], P=0.01) in patients with primary liver cancer. According to the GRADE system, the evidence for outcome measures was low to very low. The results show that Huaier Granules have certain efficacy and high safety in adjuvant treatment of primary liver cancer, but its effect in reducing adverse reactions and improve immunity remains to be verified. Due to the poor quality of the included studies and evidences, the conclusions still need to be further verified by multi-center, large sample, and randomized double-blind controlled studies.

The Platelet-Lymphocyte Ratio As a Novel Predictor of Severity in Patients With Unstable Angina Pectoris: Randomized Control Double-Blind Study

The Platelet-Lymphocyte Ratio As a Novel Predictor of Severity in Patients With Unstable Angina Pectoris: Randomized Control Double-Blind Study

Prospective randomized controlled study to compare the postoperative analgesic efficacy of intravenous dexmedetomidine and pethidine on patients undergoing lumbosacral spine surgeries

Introduction: Spine surgeries, especially spine fusion surgeries cause severe postoperative pain, hampering convalescence. This is a randomized double blind controlled study comparing the analgesic efficacy of postoperative intravenous pethidine and dexmedetomidine in patients undergoing lumbosacral spine surgeries. Materials and Methods: After connecting patients to vital parameters monitor, patients were given general anaesthesia, induced with fentanyl 2mcg/kg, propofol 2mg/kg in graded doses and rocuronium 0.6mg/kg to facilitate tracheal intubation. All patients received 1 gram paracetamol iv slow infusion intraoperatively. After one and a half hours of surgery, injection fentanyl 1mcg/kg was repeated. After extubation and shifting the patients to PACU, patients were randomly allotted either group P/pethidine group or group D/dexmedetomidine group by computerised randomization. Group P patients received injection pethidine 0.5mg/kg loading dose diluted in 5 ml of distilled water slow iv, followed by 0.15mg/kg/hr infusion for 24hrs. Group D patients received injection dexmedetomidine 1mcg/kg bolus over 15 minutes followed by infusion of 0.5mcg/kg/min. Pulse rate, blood pressure, oxygen saturation, respiratory rate, VAS score and sedation score were monitored every 5 minutes for first 15 minutes, every 15 minutes for 1 hour, every hour till 6th hour, then 12th hour, and 24th hour. Results: Dexmedetomidine has a faster on set of analgesic effect (10 minutes) compared to pethidine (30 minutes), provides better analgesia and manageable hemodynamics but, causes more sedation with an average sedation score of 2.83 compared to pethidine. Conclusion: Dexmedetomidine is a better analgesic in the postoperative period compared to pethidine. Keywords: Dexmedetomidine, Lumbosacral spine surgeries, Pethidine.

Foley's Catheter with or without Misoprostol in Induction of labor: (Randomised Double Blind Control Study)

Background: Labor induction is the initiation of labor at a viable pregnancy duration by artificial means, and occurs before the spontaneous onset of labor. The goal of labor induction is to achieve a timely and uncomplicated vaginal delivery with minimal adverse effects on the mother or newborn.Aim: This study aimed to compare the efficacy of the use of Foley’s catheter with either misoprostol or placebo to improve induction to delivery interval in women with unfavorable cervix undergoing induction of labor.Materials and Methods: The present study is a randomized double blind controlled study that that was conducted at Maternity Hospital of Ain-Shams University. The study included 100 candidates on 4 equal goups :50 nulliparas randomized into 2 groups and 50 multiparas randomized into 2 groups. Each group underwent labor induction by Foley's catheter and Misoprostol or placebo.Results: Labor stages were significantly shorter in combined group than in Foley's group, but no significant difference in third stage. Oxytocin duration and total dose were significantly lower in combined group. No significant difference among studied groups regarding mode of delivery or fetal or maternal complications.Conclusion: Combined Foleys catheter and misoprostol provides a shorter duration of cervical ripening, less oxytocin required with no added complications compared to Foley’s catheter alone.

Cerebral oximetry in adult cardiac surgery to reduce the incidence of neurological impairment and hospital length-of-stay: A prospective, randomized, controlled trial.

Cerebral oximetry using near-infrared spectroscopy (NIRS) has been shown to reduce neurological dysfunction and hospital length-of-stay after adult cardiac surgery in some but not all studies. We audited maintaining cerebral saturations at or above baseline and showed improved neurological and length-of-stay outcomes. Our hypothesis for this study was that our NIRS protocol would improve neurological and length-of-stay outcomes. This prospective, single centre, double-blinded controlled study randomized 182 consecutive patients, scheduled for cardiac surgery using cardiopulmonary bypass. Participants were randomized by concealed envelope prior to anaesthesia. NIRS study group were managed perioperatively using our NIRS protocol of 8 interventions, increase cardiac output, normocapnia, increase mean arterial pressure, increase inspired oxygen, depth of anaesthesia, blood transfusion, correction of bypass cannula, change of surgical plan to restore levels equal to or above baseline. The control group had standard management without NIRS. Primary outcomes were neurological impairment (early and late) and hospital length-of-stay. Secondary outcomes were ventilation times, intensive care length-of-stay, major organ dysfunction and mortality. 91 patients entered each group. There was a significant improvement in self-reported six-month general functionality in the NIRS group (p = 0.016). Early neurological dysfunction and hospital length-of-stay was the same in both groups. Of the secondary outcomes only Intensive Care length-of-stay was statistically significant, being shorter in the NIRS group (p = 0.026). Maintaining cerebral saturations above baseline reduces time spent in Intensive Care and may improve long term functional recovery but not stroke, major organ dysfunction and mortality.

Supplementation of Kaempferia parviflora Extract Enhances Physical Fitness and Modulates Parameters of Heart Rate Variability in Adolescent Student-Athletes: A Randomized, Double-Blind, Placebo-Controlled Clinical Study

This randomized double-blind controlled study aimed to investigate the effects of a standardized Kaempferia parviflora (KP) extract on the physical fitness and heart rate variability (HRV) parameters in adolescent sport school students. 194 male students were recruited and randomized into two groups (n = 97), matched by age and sports. The KP-treated group received KP extract capsules at a dose of 360 mg/day and the control group received placebo capsules, continuously for 12 weeks. Physical fitness performance and HRV parameters were monitored with blood biochemical analysis for product safety. KP extract significantly increased the right-hand grip strength, the back-leg strength and maximal oxygen consumption (VO2 max) and decreased the time used for 50-meter sprint test without changing the sit-and-reach test and the 40 yard technical test. For HRV parameters, KP extract significantly increased standard deviation of normal to normal intervals (SDNN), square root of the mean of square of successive normal to normal interval differences (RMSSD) and high frequency (HF) norm, without changing low frequency (LF) norm and LF/HF ratio. The increase in stress resistance and decrease in stress index were found in the KP-treated group, without changing the autonomic nervous system (ANS) activity and balance. Blood biochemical analysis showed normal values of all participants. This data indicates the safety and positive effects of KP on muscle strength, endurance and speed, but not on the flexibility and agility. The modulatory effects of KP extract on HRV parameters suggest its anti-stress effects and would encourage the application in a sport training and exercise.

Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography.

Introduction: Auricular low-level transcutaneous vagus nerve stimulation (aLL-tVNS) has emerged as a promising technology for cardiac arrhythmia management but is still experimental. In this physiological study, we hypothesized that aLL-tVNS modulated the autonomic nervous balance through a reduction of sympathetic tone and an increase in heart rate variability (HRV). We investigated the muscle sympathetic nerve activity (MSNA) recorded by microneurography during vagally mediated aLL-tVNS and active control on healthy volunteers. Methods: In this crossover, double-blind controlled study, healthy men (N = 28; 27 ± 4 years old) were assigned to aLL-tVNS applied to cymba and lobe (active control) of the right ear. Each participant was randomly allocated to the three sequences (5 Hz, 20 Hz, and active control-5 Hz) during one session. MSNA signal was recorded at rest, during voluntarily apnea and aLL-tVNS. Sympathetic activity was expressed as: 1) number of bursts per minute (burst frequency, BF) and 2) MSNA activity calculated as BF x mean burst amplitude and expressed as changes from baseline (%). RR intervals, HRV parameters and sympathetic activity were analyzed during 5 min-baseline, 10 min-stimulation, and 10 min-recovery periods. Mixed regression models were performed to evaluate cymba-(5—20 Hz) effects on the parameters with stimulation. Results: During apnea and compared to baseline, BF and MSNA activity increased (p = 0.002, p = 0.001, respectively). No stimulation effect on RR intervals and HRV parameters were showed excepted a slightly increase of the LF/HF ratio with stimulation in the cymba-5Hz sequence (coef. ± SE: 0.76 ± 0.32%; p = 0.02). During stimulation, reductions from baseline in BF (Coef. ± SE: −4.8 ± 1.1, p < 0.001) was observed but was not statistically different from that one in the active control. Reduction of MSNA activity was not significantly different between sequences. Conclusion: Acute right cymba aLL-tVNS did not induce any overall effects neither on heart rate, HRV nor MSNA variables on healthy subjects when compared to active control. Interestingly, these findings questioned the role of active controls in medical device clinical trials that implied subjective endpoints.

The influence of topical use of tranexamic acid in reducing blood loss on early operation for thoracolumbar burst fracture: a randomized double-blinded controlled study.

PurposeTo investigate the safety and efficacy of topical use of tranexamic acid (TXA) on early operation for thoracolumbar burst fracture (TBF).MethodsPatients with acute TBF requiring early decompression were prospectively collected. The enrolled patients were randomly assigned to TXA and control group, in which wound surface was soaked with TXA or the same volume of normal saline for 5 min after wound incision, respectively. The total blood loss (TBL), intraoperative blood loss (IBL), postoperative blood loss (PBL), hemoglobin (HGB) levels on preoperatively (pre-op) and postoperatively, and amount of allogenic blood transfusion were recorded. Furthermore, the general information was also compared between groups.ResultsThere were 39 and 37 patients enrolled in TXA and control group for final analysis. The demographics data showed no significant difference between groups (P > 0.05), but operation time and IBL were significantly decreased in TXA group (P < 0.05). Further analysis showed that HGB level was significantly higher in the TXA group at POD1, while the TBL and PBL were significantly less than those in the control group (P < 0.05), but similar to HBL (P > 0.05). The postoperative ambulation time, removal time of drainage tube, length of hospital stay, and blood transfusion rate were also significantly less in TXA group (P < 0.05). At the final follow-up, no neurological deteriorations and no TXA-related complications were observed in both groups.ConclusionThis RCT first demonstrated that topical TXA usage after wound incision could effectively reduce IBL without increasing risk of complications, beneficial to enhanced recovery after early operation for TBF.Electronic supplementary materialThe online version of this article (10.1007/s00586-020-06626-x) contains supplementary material, which is available to authorized users.

Effect of 2% dextrose in ringer lactate on incidence of nausea and vomiting in laparoscopic cholecystectomy-Prospective randomized control study

Post-operative nausea and vomiting (PONV) is the distressing situation for patients &amp; caregivers. Various groups of pharmalogical agents are used for prophylaxis in high risk patients for PONV but they have their own advantage and disadvantages. Recent metaanalysis on intravenous use of 5% dextrose showed conflicting results with risk of hyperglycemis. So in this study we plan to use intravenous 2% dextrose in ringer lactate for prevention of PONV in laparoscopic cholecystectomy patients.This prospective randomized double-blind controlled study was conducted in 60 American Society of Anaesthesiologist 1 &amp; 11 patients, age 20-55 years undergoing elective laparoscopic cholecystectomy under general anaesthesia. Patients were randomly divided into two groups: group DRL received 2% dextrose in ringer lactate and group RL received ringer lactate. Allocate fluid was started at induction of anaesthesia and continued post-operatively up to 6hr. Incidence and severity of PONV was measured as a primary outcome. Secondary outcome includes comparison of blood sugar level, requirement of rescue antiemetic, time of oral acceptance of food &amp; time of discharge between two groups. Mean between two groups were compared with student t test. The critical value of ‘p’ indicating the probability of significant difference was taken as&amp;#60;0.05 for comparison.Incidence and severity of PONV was less in group DRL than group RL. Blood sugar level was higher in group DRL but within the normal range. Time of oral feed and time to discharge was early in group DRL.Intravenous 2% dextrose in ringer lactate reduces the incidence and severity of PONV in laparoscopic cholecystectomy patients.

Anatomically optimized distal renal denervation — sustained blood pressure lowering efficacy during 3 years after the intervention

Aim. To test the hypothesis that anatomical optimisation of radiofrequency renal denervation (RDN) by redistribution of treatment to segmental branches of the renal artery causes a durable increase in the efficacy of the intervention.Methods. A double-blind randomised control study in parallel groups with a 3-year follow-up was performed in patients with apparent resistant hypertension (office systolic BP ≥160 or diastolic BP ≥100 mmHg despite stable treatment with ≥3 drugs, including a diuretic). Exclusion criteria were secondary hypertension, mean 24-h systolic BP &lt;135 mmHg, eGFR &lt;30 mL/min/m2 and severe comorbidity increasing procedural risks (investigator’s assessment). Eligible patients were randomised 1:1 into distal RDN or RDN in the main trunk of the renal artery. Treatment assignment was done in the operation room immediately before the procedure. For the duration of the study, the assigned treatment was unknown to patients, physicians and other outcome assessors. Long-term efficacy of the procedure was measured by changes in BP (office and ambulatory), whereas safety was assessed by changes in the 24-h protein excretion, serum creatinine and eGFR 3 years post-procedure.Results. Of the 55 randomised patients, 39 (71%) completed a 3-year assessment (21 after distal RDN and 18 after RDN in the main trunk of the renal artery). Compared to baseline, the mean 24-h BP remained significantly lowered in the distal RDN group by −16.9 (95% CI −27.3;−6.5)/−8.5 (95% CI −14.2;−2.9) mmHg, p = 0.002/0.004 (systolic/diastolic, respectively). The lowering of the mean 24-h BP was almost twofold less and non-significant in the group of RDN in the main trunk of the renal artery: −8.7 (95% CI −19.6;2.2)/−5.8 (95% CI −11.8;0.1).Conclusion. Anatomical optimisation of endovascular renal denervation produces a powerful and sustained increase in the efficacy of the intervention. Received 19 May 2020. Revised 10 July 2020. Accepted 7 September 2020. Funding: The study did not have sponsorship. Conflict of interest: Authors declare no conflict of interest. Clin.Trials.gov Identifier: NCT02667912. Author contributionsConception and design: S.E. PekarskiyData collection and analysis: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. MordovinStatistical analysis: S.E. PekarskiyDrafting the article: S.E. Pekarskiy, A.E. BaevCritical revision of the article: S.V. PopovFinal approval of the version to be published: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. Mordovin, S.V. Popov

Safety and efficacy of dexamethasone as an adjuvant to bupivacaine in bilateral transversus abdominis plane block in children undergoing major abdominal surgery

BackgroundThis prospective randomized controlled double-blind clinical study was conducted on 52 patients of both genders divided into two groups (26 patients each). Local anaesthetic solution of isobaric bupivacaine 0.25% (0.3 ml/kg) was prepared. Group A received bilateral transversus abdominis plane (TAP) block with bupivacaine and dexamethasone (0.3 mg/kg) while group B received bilateral TAP block with bupivacaine and volume of saline equal to the amount of dexamethasone given in group A. Patients were observed for FLACC pain scale at the time of discharge from the post-anaesthesia care unit and then every 2 h for 36 h after the operation. This study was conducted to assess the safety and efficacy of adding dexamethasone to bupivacaine on the quality of bilateral US-guided transversus abdominis plane (TAP) block in children undergoing major abdominal surgeryResultsDexamethasone added to local anaesthetic in ultrasound-guided TAP block significantly decreased FLACC score at 8, 10, and 12 up to 24 h postoperatively, The time to the first requested analgesia was prolonged in the dexamethasone group (P = 0.000). The total dose of acetaminophen consumption over 36 h after surgery was also reduced (P = 0.000), but no difference was found regarding the total dose of rectal diclofenac (P = 0.068).ConclusionAdding dexamethasone to isobaric bupivacaine TAP block reduces postoperative pain and analgesic requirements compared to isobaric bupivacaine TAP block alone in children undergoing major abdominal surgery.

"Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial."

Despite widespread phototherapy usage, many new-born infants remain in need of other invasive lines of therapy, such as intravenous immunoglobulins and exchange transfusions. Assessment of the efficacy and the safety of adding fenofibrate to phototherapy for the treatment of pathological jaundice in full-term infants. We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU at Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg/kg/day for 1 day or 2 days or placebo in addition to phototherapy. The primary outcome was total serum bilirubin values after 12, 24, 36, 48, and 72 h from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate. This study was registered at www.clinicaltrials.gov (NCT04418180). A total of 180 full-term infants were included, 60 in each group. Infants in group I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively. Fenofibrate administration was associated with significantly shorter duration of phototherapy, shorter hospital stay, and higher frequency of exclusive breast-feeding compared to phototherapy alone. Fenofibrate as an adjuvant to phototherapy in term neonate with pathological jaundice is well tolerated and associated with significant reduction of serum bilirubin levels, a shorter duration of phototherapy, shorter hospital stay and higher frequency of exclusive breast-feeding, without significant adverse effects in either the single or double dosage.