Double-blind Comparative Study Research Articles

Comparison of efficacy of intrathecal hyperbaric ropivacaine and hyperbaric bupivacaine in terms of enhanced recovery after surgery (ERAS) for ACL reconstructions

: Bupivacaine is the drug of choice in spinal anaesthesia (SA), while Ropivacaine with its comparatively shorter duration of motor block allows early mobilization post ACL reconstruction surgery which is a crucial factor in Early Recovery after Surgery. : In this randomized double-blind comparative study of a total of 60 patients irrespective of gender undergoing ACL reconstruction surgery were studied. After Administration of SA to group R (2.5ml of 0.75% Heavy Ropivacaine) & group B (2.5ml of 0.5% Bupivacaine) both were compared for their post-operative effects with Bromage score, Aldrete score & Visual Analogue Score. : The time required for complete regression of motor blockade in group R (144.5+26.1 mins) < group B (181±21.3mins) which allowed for early mobilization which over all provides better and faster recovery.: Hyperbaric Ropivacaine when compared to Bupivacaine promises better results in terms of early ambulation and intraoperative hemodynamic stability promoting ERAS in patients undergoing ACL reconstruction surgeries. Promoting ERAS policy will reduce the duration of hospital stay, thereby improving the cost-effectiveness of health services.

Efficacy, Safety and Immunogenicity of Sun's Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study.

The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5mg (0.05mL) intravitreal injection of either Sun's ranibizumab or reference ranibizumab in the study eye every 4weeks until week 16 (total of four doses). Primary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week16 (99% of patients in Sun's ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at -1% (-2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun's ranibizumab group and 37% of the reference ranibizumab group (p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun's ranibizumab group and 14.6 letters in the reference ranibizumab group (p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups (p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated. Sun's ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns. CTRI/2020/09/027629, registered on 07 September 2020.

Prospective randomized double-blind comparative study of topical acetyl zingerone with tetrahexyldecyl ascorbate versus tetrahexyldecyl ascorbate alone on facial photoaging.

Tetrahexydecyl ascorbate (THDA) is a lipophilic precursor to ascorbic acid that may be stabilized by acetyl zingerone (AZ). Studies have shown that the topical application of THDA may have photoprotective effects. Similarly, AZ has been shown to mitigate oxidative and inflammatory stress, thereby improving the appearance of photoaging. To examine the effects of THDA and AZ (THDA-AZ) on skin photoaging compared to THDA alone. In this double-blind, randomized controlled trial, healthy individuals aged 30 to 65 were included and 44 participants were randomized to receive either THDA-AZ (THDA 5% + AZ 1%) or THDA only (THDA 5%) for 8 weeks. Facial photographs were taken at 0, 4, and 8 weeks to analyze wrinkle severity, pigment intensity, and redness intensity. A skin colorimeter was used to assess infraorbital pigmentation and erythema. Self-perception of skin and tolerability were assessed through questionnaires. Average wrinkle severity was significantly decreased in the THDA-AZ group at Weeks 4 and 8 by 0.75% (p = 0.023) and 3.72% (p = 0.048), respectively, compared to the THDA group where wrinkle severity at Weeks 4 and 8 was increased by 7.88% and 4.48%, respectively. Facial pigment intensity was significantly decreased in the THDA-AZ group by 4.10% (p = 0.0002) at Week 8 compared to a 0.69% decrease in the THDA group. Facial redness intensity was decreased in the THDA-AZ group at Weeks 4 and 8 by 3.73% (p = 0.0162) and 14.25% (p = 0.045), respectively, compared to the THDA group where at Weeks 4 and 8 erythema increased by 27.5% and 8.34%, respectively. There were no significant differences in either group for infraorbital pigmentation or erythema. Daily use of combined THDA and AZ may improve facial wrinkle severity, pigment intensity, and erythema to a greater extent than THDA. While THDA alone increases facial wrinkle severity and erythema, the addition of AZ reduces both.

Anxiolytic and Sedative Properties of Melatonin Premedication in Pediatrics Undergoing Elective Cardiac Catheterization: A Randomized Placebo Study.

Preoperative anxiety in children has been linked to various postoperative consequences, such as postoperative regressive behavioral issues, extended distress during the recovery period, eating disorders, and bedwetting. The current study aimed to investigate the efficacy of low-dose oral melatonin in alleviating preoperative anxiety among children in the Iraqi population. A randomized, double-blinded comparative study was undertaken, involving children aged four to 14 years scheduled for elective cardiac catheterization under general anesthesia. The study comprised a total of 80 children. The involved individuals were randomly assigned to two groups, each with 40 subjects. Group A received 0.5 mg/kg melatonin as premedication, while Group B received a placebo. The two groups demonstrated similarity in mean age, weight, cardiac disease, and gender distribution. Statistically significant reductions in anxiety scores were observed in the melatonin group compared to the placebo group. Particularly, children administered 0.5 mg/kg melatonin exhibited the most substantial anxiolysis and venipuncture compliance (P < 0.05). Additionally, children who were premedicated with melatonin experienced decreased cognition, maximum sedation, successful parental separation, and psychomotor impairment (P < 0.05). Melatonin demonstrated an effective sedation level without significant side effects, making it a preferred choice due to its efficacy, safety, current availability, and cost-effectiveness compared to other anesthetic agentsused in premedication procedures.

Effect of erinacine A-enriched Hericium erinaceus supplementation on cognition: A randomized, double-blind, placebo-controlled pilot study

Population aging has led to an increased interest in various dietary supplements in order to preserve cognitive function. The aim of our study was to examine the effects of Hericium erinaceus supplementation (HE) on cognitive function and serum levels of Brain-Derived Neurotrophic Factor (BDNF) and Neuropeptide Y (NPY). An 8-week double-blind comparative study involved 33 subjects, randomly assigned to a HE group and a placebo (P) group. Anthropometric measurements and analyses of selected biochemical parameters were performed before and after the intervention. Simultaneously, faecal samples were collected to determine gut microbiota and chitinase 3-like-1 (CHI3L1) levels. Cognitive function was assessed using two non-verbal speed tests. In the HE group, a significant improvement in cognitive ability was observed when the corresponding cognitive scores at baseline, CHI3L1 level, age, and gender were considered. Moreover, in the HE group there was a significant increase in gut microbiota diversity that was positively correlated to NPY levels. The mechanism that could help to explain the results on the relationship between the active ingredients of the H. erinaceus and the cognitive parameters could point to the CHI3L1 activity that may enhance bioavailability of the bioactive ingredients. Supplementing the diet with HE was recognised as a safe and well-tolerated intervention with a neurocognitive benefit.

(029) Safety and Efficacy of Botulinum Neurotoxin in the Treatment of Erectile Dysfunction Refractory to Phosphodiesterase Inhibitors: Results of a Randomized Controlled Trial

Abstract Introduction There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation. Objective To evaluate the safety and efficacy of intracavernosal BoNT-A injection in the treatment of patients with erectile dysfunction (ED) refractory to oral phosphodiesterase inhibitors (PDE5Is). Methods A double-blind randomized placebo-controlled prospective comparative study conducted at one center and involved 70 patients with ED refractory to PDE5Is. At baseline, the following data were collected: erection hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), sexual health inventory for men (SHIM), and the sexual encounter profile 2&amp;3 (SEP-2&amp;3) questionnaires. Treatment group (n = 35) received a single ICI of 100 units of BoNT-A in 2 ml of saline and control group (n = 35) received a single ICI of 2 ml of saline. EHS, PSV, and EDV were assessed at 2 weeks post treatment. SHIM, SEP-2, SEP-3, and global assessment questionnaire (GAQ-Q1&amp;Q2) were completed at 2-, 6-, and 12-weeks post treatment. Results Two weeks post treatment, the treatment group showed a statistically significant improvement in the mean EHS, PSV, EDV, and GAQ-Q1 positive responders (p &amp;lt; 0.001) compared to the control group. At 6- and 12-weeks post treatment, the treatment group showed a statistically significant improvement in the SHIM scores, SEP-2, and GAQ-Q1&amp;Q2 positive responders compared to the control group. At 6 weeks, where there was a 5-point improvement in the mean SHIM score of the treatment group (10±5.9 from 5.4±1.7 at baseline) versus no improvement in the placebo group, 18 patients in the treatment group (53%) were able to have an erection hard enough for vaginal penetration versus only one patient in the control group. Conclusions BoNT-A is safe and effective as a potential treatment for ED refractory to PDE5I therapy. Disclosure No.

Nebulized Versus Intravenously Administered Dexmedetomidine for Obtunding Hemodynamic Responses to Laryngoscopy and Tracheal Intubation: A Randomized Double-Blind Comparative Study.

Introduction Intravenous dexmedetomidine is known to cause major adverse effects such as bradycardia, hypotension, cardiac arrhythmias, and heart block when used as premedication for attenuation of the laryngoscopy and intubation response, limiting its routine use. Thus, it is important to study other routes of administration of dexmedetomidine. Objectives To compare the hemodynamic response and sedation score between intravenous and nebulized dexmedetomidine as premedication for the attenuation of the laryngoscopy and intubation response. Materials and methods In this study, 60 patients fulfilling inclusion criteria undergoing surgeries under general anesthesia (ASA Grade I and II) were randomly allocated into two groups of 30 patients each. Group IV received intravenous 1 mcg/kg dexmedetomidine in 100 mLnormal saline, and Group IN received nebulization with 1 mcg/kg dexmedetomidine diluted to a total volume of 5 cc of normal saline, 30 minutes prior to the induction of general anesthesia. Sedation scores were calculated using the Ramsay sedation score at 20 minutes after the administration of the drug; patients were induced by the standard protocol, and laryngoscopy was performed. Vitals were recorded before the administration of the drug and after intubation at stipulated time intervals. Results The median heart rate becomes significantly lower at 15 minutes (70 vs. 76.5) and 20 minutes (66 vs. 76) after induction among Group IV as compared to Group IN. The median systolic blood pressure was significantly lower at 20 minutes in Group IV (110 mmHg) than in Group IN (119 mmHg). The median diastolic blood pressure was significantly lower at 10 minutes (76 vs. 79), 15 minutes (70 vs. 77), and 20 minutes (69 vs. 78.5) in Group IV than in Group IN. The median of mean arterial pressure was significantly lower at 15 minutes (84.8 vs. 91.5) and 20 minutes (83 vs. 92) in Group IV than in Group IN. A comparison of vitals after induction shows that the median heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure were significantly lower statistically among Group IV as compared to Group IN at 0, 1, 3, 5, 10, 15, and 30 minutes after induction (except for systolic blood pressure at 3 minutes). The median sedation score was lower in Group IN (0) than in Group IV (1); this difference is statistically significant. Conclusion The obtundation of hemodynamic responses following laryngoscopy and maintaining hemodynamics intraoperatively is statistically better with nebulized dexmedetomidine compared to intravenous dexmedetomidine.

Significantly Enhanced Improvement in Dryness, Roughness, Fine Lines and Radiance Following Daily Use of a Novel Multi-Weight Hyaluronic Acid Plus Antioxidant Complex-Based Lotion Compared to a Single-Weight HA Plus Ceramide-Based Lotion

Introduction: Hyaluronic acid (HA) has become a commonly used ingredient in many topical moisturizing products due to its strong humectant properties and essential role in skin hydration; however, limitations of delivery of HA to only the surface of skin has hindered leveraging the full capacity of HA biology necessary for skin rejuvenation. Here we describe the head-to-head clinical comparison of a novel multi-weight HA plus antioxidant complex-based lotion with SPF 30 and a single-weight plus ceramide-based lotion with SPF 30 for clinical efficacy on dryness, roughness, fine facial lines, and radiance following daily use. Methods: A double-blind comparative study was conducted on 70 female subjects (n=35, multi-weight HA plus antioxidant complex-based lotion with SPF 30; n=35, single-weight plus ceramide-based lotion with SPF 30) ages 25 to 65 years with mild to moderate facial dryness and visible fine lines and wrinkles, including subjects with Fitzpatrick Skin Types I-VI, with 20% having Fitzpatrick Skin Types V-VI. Clinical grading of the face including dryness, roughness, and fine lines were assessed at baseline, 30 minutes, 2 weeks, 4 weeks, and 8 weeks after once daily application in the morning. Visible, cross-polarized (X-Pol), parallel-polarized (P-Pol) and UV fluorescence clinical images were acquired for each time point. X-Pol and P-Pol images were used to quantify skin radiance. Results: Daily use of the multi-weight HA plus antioxidant complex-based lotion with SPF 30 demonstrated significant improvements in all clinical grading assessments of dryness, fine lines, and wrinkles as early as Week 2 compared to baseline. Improvements in visible dryness (Week 2), roughness (Week 2), and fine lines (Week 8) were greater for the multi-weight HA plus antioxidant complex-based lotion with SPF 30 compared to the single-weight HA plus ceramide-based lotion with SPF 30, with overall statistical significance across all three parameters assessed favoring the multi-weight HA plus antioxidant complex-based lotion with SPF 30. For radiance, daily use of the multi-weight HA plus antioxidant complex-based lotion with SPF 30 demonstrated significant increase in radiance at Week 4 compared with baseline, while the single-weight HA plus ceramide-based lotion did not show any improvement in skin radiance compared with baseline. Conclusions: The marked improvements in dryness, roughness, fine lines, and radiance following daily utilization of the multi-weight HA plus antioxidant complex-based lotion with SPF 30 may be attributed to the inherent properties of HA. These improvements may be further attributed to the ability of multi-weight HAs to moisturize the skin surface and penetrate the upper surface layers of the skin, combined with the added benefits of key antioxidants, including glycine saponin and glycyrrhetinic acid, which have been previously shown to induce endogenous HA synthesis and inhibit endogenous hyaluronidase activity in vitro, respectively.

A Randomized Double Blind Comparative Study of Intrathecal Dexmedetomidine and Magnesium Sulfate for Post-spinal Anesthesia Shivering in Lower Segment Cesarean Section

A Randomized Double Blind Comparative Study of Intrathecal Dexmedetomidine and Magnesium Sulfate for Post-spinal Anesthesia Shivering in Lower Segment Cesarean Section

Study on safety and efficacy of tablet thiocolchicoside 4 mg + tablet aceclofenac 100 mg versus tablet aceclofenac 100 mg + tablet paracetamol 500 mg in treatment of patients with acute lower back pain: A randomized double-blind comparative study

Background: Lower backache is a highly prevalent condition among middle-aged individuals and is often caused by muscle spasms. It is one of the most common reasons why people seek medical assistance from a primary care physician. Aims and Objectives: The aims and objectives of the study are to evaluate the safety and efficacy of the drug combinations thiocolchicoside 4 mg and aceclofenac 100 mg versus aceclofenac 100 mg and paracetamol 500 mg. Materials and Methods: The study was conducted using a prospective, randomized, double-blind, comparative, and parallel group design. A total of 80 patients who met the specified criteria were selected to participate in the trial over a period of 3 months. A total of 30 cases were selected for each group, with consideration given to excluding outliers. The patients were allocated randomly into two groups: Group A, consisting of 30 individuals, and Group B, consisting of 30 individuals. The primary efficacy assessments include the visual analog scale, muscle spasm assessment by finger-to-floor distance, and Lasegue’s maneuver. The secondary efficacy measures were assessed using a 4-point scale global assessment, which included ratings of excellent, good, average, and poor. Results: The majority of study participants were in the age group 39–48 years and above 48 years consisting of 25 patients and 33, respectively. Males constituted 51.6% and females were 48.3%. On day 28, results were calculated on 26 patients in Group A and 24 patients in Group B as 10 patients discontinued the treatment after 3rd week. Conclusions: It is concluded that the best possible medical intervention to treat acute low back pain is to use drug combinations of analgesics and skeletal muscle relaxants. The combination of tablet thiocolchicoside and aceclofenac proved to be more efficacious and safer when compared to the combination of tablet aceclofenac and paracetamol.

A Prospective Randomized Double Blind Comparative Study to Determine the Efficacy of Norepinephrine and Ephedrine to Maintain Arterial Blood Pressure During Spinal Anesthesia for Cesarean Delivery

Background: Spinal Anesthesia Induced Hypotension(SAIH) continues to be the troublesome complication for obstetric patients undergoing cesarean section under subarachnoid block. Vasopressors are emerging as the cornerstone of treating SAIH in cesarean section patients with the evolving evidence of arterial vasodilatation as the primary cause of hypotension. This study was hypothesized to compare the efficacy of norepinephrine and ephedrine boluses to maintain hemodynamics in cesarean section.&#x0D; Methods: After approval from institutional ethics committee and registration in Clinical Trials Registry India(CTRI ) and informed consent, study was conducted in 110 healthy parturients aged 18-40 years, belonging to ASA physical status I and II, posted for elective cesarean section under spinal anesthesia, were randomly allocated into group N(n=55) and group E(n=55),who received intravenous boluses of norepinephrine 6 g and ephedrine 10mg respectively as prophylaxis(one dose soon after induction) and in treatment of SAIH. The number of vasopressor boluses were recorded as primary objective and hemodynamics, APGAR scores, adverse events were noted.&#x0D; Results: The number of boluses of vasopressor used was 1.9±1.2 for Ephedrine and 4.72±2.9 for Norepinephrine. At 30,40,50 and 60 minutes after anesthesia, there was significant fall in mean arterial pressure in the norepinephrine group compared to ephedrine group. The incidence of tachycardia was more in ephedrine group and incidence of bradycardia was more in norepinephrine group.&#x0D; Conclusion: Both the study drugs, ephedrine and norepinephrine are comparably effective in preventing SAIH after prophylactic bolus and effective in maintaining blood pressure intraoperatively, more number of boluses of norepinephrine was required compared to ephedrine.

A comparative study on sedative and cardiorespiratory effects of clonidine and dexmedetomidine added to ropivacaine in supraclavicular brachial plexus block in upper extremity surgery

Background: Supraclavicular brachial plexus block is widely used peripheral nerve block technique used for surgery of the upper extremity. Several drugs have been used with local anesthetic as adjuvants for rapid, dense, and prolonged analgesia. Aims and Objectives: The aims and objectives of the study are to compare the degree of sedation and cardiorespiratory effects of clonidine and dexmedetomidine added to ropivacaine in supraclavicular brachial plexus block. Materials and Methods: A double-blinded comparative study was done on eighty patients who were randomly allocated equally into two groups and received clonidine and dexmedetomidine added to ropivacaine 0.5%. Intraoperative degree of sedation and cardiorespiratory parameters were monitored in regular intervals and compared to find difference. Results: Heart rate was consistently lower with dexmedetomidine. Systolic, diastolic, and mean arterial pressures (MAPs) were comparable in both groups at all time points except at 45 min when diastolic and MAP were lower with dexmedetomidine and it was statistically significant. Sedation score in Group D was higher except at 5 min and difference was statistically significant. All patients in both groups were sedated and easily arousable. There was statistically significant difference in peroperative oxygen saturation between the groups although it was clinically not significant. Conclusion: There was more hemodynamic effect of dexmedetomidine than clonidine but these effects can be managed by medication easily. In addition to this, it was found that dexmedetomidine provides conscious sedation without any respiratory depression. Comparing the risk and benefit dexmedetomidine can be used with local anesthetic in supraclavicular brachial plexus block in upper extremity surgery.

A randomized comparative study of transversus abdominis plane block (tap) with 0.25% bupivacaine and 0.375% ropivacaine in the duration of post-operative analgesia in upper abdominal laparoscopic surgeries

Transversus abdominis plane (TAP) block is a successful postoperative analgesia technique in laparoscopic surgeries. This study compared the analgesic efficacy of 0.25% bupivacaine and 0.375% Ropivacaine in TAP block as post-operative analgesia for upper abdomen laparoscopic surgeries.: This randomized, double-blinded comparative study was conducted at the Dr Jeyasekharan Medical Trust and Nursing Home for 18 months. Seventy-one consenting adult patients undergoing upper abdominal laparoscopic surgeries qualifying the inclusion criteria to undergo Bilateral Subcostal TAP Block were included. The patient was labelled group A or B according to a computer-generated randomization list. TAP block was administered using 30 ml (15 ml on each side) of 0.25% bupivacaine (A) or 0.375% ropivacaine (B). Similar premedication and induction were given to all patients. : Among 71 patients in group A, males were 5 (14.7%), and females were 29 (85.3%). In group B, males were 7 (18.9%), and female was 30 (81.1%). There is no significant difference in gender, age, and BMI between groups. The mean duration of analgesia with 0.375% ropivacaine (10.21±3.36 hrs.) was significantly higher than 0.25% bupivacaine (6.38±2.03 hrs.). In the first 24 hours postoperatively, the mean total tramadol consumption was 147.06±11.94 mg in group A and 117.57±31.11 mg in group B, which is statistically significant.: This study concludes that 0.375% 30ml ropivacaine given as a TAP block under ultrasound guidance significantly prolonged the post-operative analgesia duration compared to 0.25% 30ml bupivacaine.

A Single-Center, Randomized, Double-Blind, and Placebo-Controlled Comparative Human Study to Verify the Functionality and Safety of the Lespedeza cuneata G. Don Extract for the Improvement of Aging Male Syndrome.

Aging male syndrome is a clinical biochemical syndrome characterized by typical aging symptoms and serum testosterone deficiency. Although it is accompanied by various health problems, directly affects life satisfaction, and requires proper management, no clear prevention or treatment other than hormone replacement therapy is currently available for this syndrome. Here, we aimed to determine the efficacy and safety of the Lespedeza cuneata extract in the management of the aging male syndrome. Males aged 43-70 years who provided consent for participation and had a total Aging Males' Symptom questionnaire score ≥ 37 and testosterone level ≤ 500 ng/dL were enrolled in this study. This study was conducted in a randomized, double-blind manner. Participants were randomly assigned to either the experimental or control groups and orally administered the assigned product twice a day. Efficacy was evaluated by measuring changes in Aging Males' Symptom score, Androgen Deficiency in the Aging Male questionnaire score, International Index of Erectile Function score, International Prostatic Symptom Score, blood test results, and body mass index at 8 weeks. After 8 weeks, the experimental group had significantly improved symptom scores compared to the control group on the Aging Males' Symptom and Androgen Deficiency in the Aging Male questionnaires. However, no significant differences in the International Index of Erectile Function score, International Prostatic Symptom Score score, blood test results, and body mass index were observed between the experimental and control groups. Lespedeza cuneata extract safely alleviates andropause symptoms without any significant side effects, suggesting its potential for the treatment of the aging male syndrome.

Combined FOLFOX4 with all-trans retinoic acid versus FOLFOX4 with placebo in treatment of advanced hepatocellular carcinoma with extrahepatic metastasis: a randomized, double-blind comparative study

The majority of hepatocellular carcinoma (HCC) cases are diagnosed at an advanced stage. Currently, there are only a few therapeutic methods available for patients with advanced HCC and extrahepatic metastasis (EHM). Systemic chemotherapy, such as FOLFOX4 (infusions of fluorouracil, leucovorin, and oxaliplatin), has been reported for treating advanced HCC with EHM, but its effectiveness is very poor. In this randomized, double-blind, placebo-controlled study, we aimed to assess the efficacy and safety of FOLFOX4 with all-trans-retinoic acid (ATRA) as a palliative treatment for HCC patients with EHM, compared to FOLFOX4 with a placebo. The primary endpoint was overall survival (OS), and subsequently, an exploratory model was developed based on bioinformatics to predict the efficacy of FOLFOX4-ATRA treatment. A total of 108 patients were randomly assigned in a 1:1 ratio to receive either FOLFOX4-ATRA or FOLFOX4-placebo. The intention-to-treat (ITT) population showed a median OS of 16.2 months for the FOLFOX4-ATRA group, compared with 10.7 months for the FOLFOX4-placebo group (HR 0.56, 95% CI 0.33–0.93; p = 0.025). The median progression-free survival (PFS) was 7.1 months for the FOLFOX4-ATRA group and 4.2 months for the FOLFOX4-placebo group (HR 0.62, 95% CI 0.41–0.94; p = 0.024). A panel of proteins with unique upregulation during complete response (CR) (SOD3, TTR, SSC5D, GP5, IGKV1D-33) and partial response (PR) (TGFB1, GSS, IGHV5-10-1) effectively predicted CR and PR in patients treated with FOLFOX4-ATRA, as compared to FOLFOX4-placebo. The results suggest that FOLFOX4-ATRA is a safe and effective treatment for patients with advanced HCC and EHM in eastern China.

A Randomized Double-Blind Comparative Study of the Intubating Conditions and Hemodynamic Effects of Rocuronium and Succinylcholine in Pediatric Patients.

The incidence of unanticipated difficult airways is higher in pediatric age groups than in adults due to the different airway anatomy, difficulty in airway examination, and congenital malformations. Rocuronium bromide has a comparable onset time to succinylcholine at its proportionate dose. Hence, we compared rocuronium bromide with succinylcholine to assess intubating conditions and their side effects, if any. A total of 200 pediatric patients ofAmerican Society of Anesthesiologists (ASA) grades I and II between one and 14 years of age of either sex posted for elective surgery were included in the study. After randomization, group R (n = 100) received 1.2 mg/kg rocuronium, and group S (n = 100) received 2 mg/kg succinylcholine intravenously. After confirming the mask ventilation, the study drugs were administered, and intubating conditions were assessed as excellent, good, poor, or impossible. Hemodynamic changes post-intubation were recorded as our secondary outcome. Intubating conditions were excellent( 65%), good( 25%) and fair (10%) in patients of group R, while results in group S were excellent( 60%), good( 20%), fair (15%), and poor (5%) (p = 0.010). The heart rate was significantly increased post-intubation in group S, while there was no significant increase in systolic or diastolic blood pressure in either group. At a dose of 1.2 mg/kg body weight, rocuronium was a better alternative to succinylcholine for providing rapid intubating conditions and stable hemodynamics without associated adverse effects.

Efficacy of Incisional Ropivacaine Infiltration by Presternal Multi-Orifice Catheter for Post-sternotomy Pain Relief in Pediatric Patients Undergoing Cardiac Surgery: A Prospective, Randomized, Controlled Study

To evaluate the efficacy of incisional ropivacaine infiltration by presternal multi-orifice catheter to manage poststernotomy pain in pediatric cardiac surgery. A prospective, randomized, and double-blind comparative study. At a single-institution tertiary referral cardiac center. The study comprised 200 children undergoing cardiac surgeries through a midline sternotomy. Children were allocated randomly to 1 of 3 groups. Group A (n=65) and group B (n=64) received 0.375% ropivacaine infusion and intermittent bolus, respectively, by presternal multi-orifice catheter, whereas Group C (n=64) did not receive any local anesthetic (LA) drug. Postoperatively, intravenous paracetamol was used for multimodal analgesia, and fentanyl was given as rescue analgesia, respectively. Pain was assessed by a Modified Objective Pain Score (MOPS) for 48 hours postextubation. Group B had significantly lower early MOPS at the first hour, but in the later period, the mean MOPS was lower in group A. The requirement of the first rescue analgesia was 3 ± 1.51, 6.1 ± 2.26, and 2.6 ± 0.87 hours for groups A (n=60), B (n=60), and C (n=60), respectively. The 48-hour fentanyl consumption was significantly lower (p < 0.001) in group A (0.5 ± 0.68 µg/kg) and group B (0.7 ± 0.86 µg/kg) than the control group (3.4 ± 0.68 µg/kg). The length of intensive care unit stay was lower (p < 0.001) in groups A and B than in group C; however, the length of hospital stay was comparable (p=0.07). LA bolus and infusion through presternal multi-orifice catheter provided effective analgesia postoperatively. However, the bolus was more efficacious in the early phase but equivalent in later periods. Therefore, bolus and LA infusion can be used for steady poststernotomy pain relief in children undergoing cardiac surgeries.

A comparative study of intravenous dexmedetomidine and clonidine as pre-emptive analgesia to intrathecal bupivacaine in subarachnoid block - A randomized double blind study

: Several drugs and drug regimens are used as adjuncts to local anaesthetics for neuraxial blockade in order to enhance its efficacy. In recent times novel drugs, adrenergic agonists like dexmedetomidine and clonidine are extensively used. Very few studies have compared the equipotent doses of both the drugs when given as pre-emptive analgesia. This study compares the efficacy of pre-emptive intravenous dexmedetomidine and clonidine for prolongation of bupivacaine spinal anaesthesia.: This is a prospective double-blind comparative study conducted at a tertiary care center from January 2021 to May 2022. 90 participants satisfying inclusion criteria were chosen after obtaining ethical Committee approval and informed consent. Study participants were randomly divided into two groups. Group C (n=45) received clonidine 0.5mcg/kg IV and Group D (n=45) received 0.5mcg/kg IV over 10mins following which subarachnoid block was given with hyperbaric bupivacaine 0.5% 15mg intrathecally. The following parameters were measured as onset, duration of sensory and motor blockade, duration of analgesia and number of rescue analgesics given in the postoperative period. Onset of sensory blockade (2.40+ 0.81) and motor blockade (2.78+ 0.88) was significantly faster in group D when compared to group C. Sensory blockade duration in group C and D was (100.22+ 11.38) and (129.33+ 13.55) respectively and was statistically significant. Similarly, Motor blockade duration was prolonged in group D (156.67+ 12.25) than in group C (121.78+ 14.35). Mean duration of analgesia in group D (169.51+19.23) and group C (143.8+18.78) illustrated statistically significant difference.: Dexmedetomidine when given as a pre-emptive analgesia enhances the effectiveness of bupivacaine by prolonging its duration of action when compared to clonidine at given doses.

COMPARISON OF 0.5% LEVOBUPIVACAINE- FENTANYLAND 0.5% ROPIVACAINE-FENTANYL IN INFRAUMBILICAL SURGERIES

Spinal anaesthesia is a commonly performed procedure when the surgical site is located on the lower abdomen, perineum or lower extremities. The advantages are an awake and spontaneously breathing patient, minimal drug costs, reduction of poly-pharmacy and rapid patient turnover. Regional anesthesia techniques have seen numerous modifications over the last two decades with the advent of many new and safer local anesthetics. Presently, hyperbaric bupivacaine is the most commonly used drug for administration of spinal anaesthesia. Levobupivacaine and ropivacaine have recently become available in India for clinical use. Very few studies have been done comparing these two drugs in India. Hence, present study was undertaken to compare 0.5% Levobupivacaine (isobaric)-fentanyl(25µg) and 0.5% Ropivacaine (isobaric)-fentanyl(25µg)with regards to onset and duration of blockade infra umbilical surgeries in spinal anaesthesia. Methods and materials- this is a hospital based randomized double blinded comparative clinical study. Adult patients scheduled for elective infra umbilical surgeries under spinal anaesthesia. Eighty patients were randomized to two groups: group LF and RF (n=40 for each group). All patients received drug volume of 3.5ml containing 3 ml isobaric levobupivacaine (15 mg) + 0.5 ml (25 mcg) fentanyl in group LF, and 3ml isobaric ropivacaine (15mg) + 0.5 ml (25 smcg) fentanyl in group RF. The time for completion of intrathecal administration of study drugs injection is considered as TIME 0. The following parameters were observed – time of onset and duration of sensory block, motor block. Results: In the present study, mean onset of sensory block was faster in Group LF (5.25±0.74 min) than in Group RF (6.53 ± 0.51 min) and was statistically significant (p value &lt; 0.001). In the present study, mean onset of motor block was faster in Group LF (7.25±0.98 min) than in Group LF (11.2 ± 0.61 min) and was statistically significant (p value &lt;0.001). Conclusion: LF group provided better sensory and motor blockade with higher dermatome coverage than RF group.

Comparison of Baska Mask Versus Proseal Laryngeal Mask Airway in Elective Surgeries Under General Anaesthesia: A Randomized Clinical Trial.

Background Baska Mask (BM) is a third-generation supraglottic airway device with a self-inflating cuff. This study aimed to evaluate the efficacy of the BM compared to ProSeal laryngeal mask airway (PLMA) regarding insertion time, ease of insertion, and oropharyngeal seal pressure in patients undergoing elective surgeries under general anesthesia for less than two hours. Methods This prospective, randomized, double-blind comparative study was done on 64 patients randomly divided into two groups, with 32 patients in the PLMAgroup (Group A) and 32 in the BM group (Group B). Individuals with a body mass index (BMI)of more than 30, a history of nausea/vomiting, or pharyngeal pathology were excluded from the trial. After induction with propofol 3-4 mg/kg, fentanyl 1-2 mcg/kg, and the neuromuscular blockade was achieved with atracurium 0.5 mg/kg, patientswere insertedwitheither BM (n= 32) or PLMA (n= 32). The primary outcome measure was the time taken for insertion and ease of insertion. Secondary outcome measures included the number of attempts, oropharyngeal seal pressure (OSP), and laryngopharyngeal morbidity (trauma to lips, blood staining, and sore throat) immediately and 24 hours postoperatively. Results Demographic data were comparable and statistically insignificant. Regarding time and ease of insertion, the BM could be inserted in a lesser time of 24±1.136 seconds compared to PLMA which took 28.59±1.682 seconds, with a high success rate in the first attempt which wasstatistically significant. The BMprovided a higher OSP(31.34 +1.638 cmH2O)when compared to PLMA(24.81±1.469 cmH2O) andwas statistically significant. Complications associated with insertion trauma to the lip, blood staining, and sore throat were more in PLMA (15.6%, 15.6 %, 9.4%, respectively) compared to the BM (6.3%, 3.1%, 3.1%, respectively), and statistically insignificant. Conclusion BM had higher first-attempt successful insertion with better OSP compared to PLMAin patients under controlled ventilation.