Background:The conventional technique of ilioinguinal and iliohypogastric nerve block may be associated with drug toxicity, block failure and needs large drug volume. The ultrasound-guided (USG) nerve block enables accurate needle positioning that may reduce the chances of drug toxicity, drug dose and block failure.Aim:In this study, we compared the onset and duration of the motor and sensory nerve block, the drug volume required and time to rescue analgesic between USG and conventional technique.Settings and Design:Sixty male patients aged between 18 and 60 years, belonging to American society of Anesthesiology I-II, scheduled for inguinal hernia repair were enrolled in this prospective study and were randomly allocated into two groups of thirty each by computerized method.Materials and Methods:Group A patients received hernia block by conventional method using 0.75% ropivacaine 15 ml, and Group B patients were given the block guided by ultrasound using 0.75% ropivacaine, till the nerves were surrounded on all sides by the drug.Statistical Analysis:The data were analyzed using two independent sample t-tests for demographic and hemodynamic parameters. Nonparametric test (Mann-Whitney U-test) was used to find the significance between visual analog scale.Results:There was significantly early onset of sensory block in Group B 14.03 ± 2.82 min as compared to Group A 15.57 ± 1.52 min (P = 0.047). The onset of motor block was also earlier in Group B 19.40 ± 2.85 min as compared to Group A 20.67 ± 1.90 min. The time to rescue analgesia was more in Group B 7.22 ± 0.97 h as compared to Group A 6.80 ± 0.70 h (P = 0.062). The volume of drug required was less with ultrasound guided block.Conclusions:Ultrasound-guided hernia block thus has the advantage of early onset, less dose requirement and increase in time to rescue analgesia.
Background:Pressor response is a part of stress response caused by reflex sympathetic discharge due to direct laryngoscopy and tracheal intubation resulting in tachycardia, hypertension and arrhythmias. Both clonidine, and gabapentin administered orally can effectively blunt this detrimental hemodynamic response.Aim:To study the effect of oral clonidine to blunt the pressor response to direct laryngoscopy and to compare it with oral gabapentin. To observe for postoperative sedation and side effects if any.Settings and Design:Sixty patients of American Society of Anaesthesiologist Grade I and II scheduled for surgery under general anesthesia were considered in this prospective randomized double-blind study. They were randomly allocated into two groups of 30 each using computerized randomization.Materials and Methods:Group A was given oral clonidine 5 μg/kg and Group B was given oral gabapentin 800 mg. Both the drugs were given 90 min prior to surgery. Heart rate (HR) and blood pressure were monitored at baseline, 0, 1, 3, 5, 10, 15, and 30th min of laryngoscopy. Sedation was monitored by Ramsay Sedation Scale score and side effects were noted.Results:HR decreased in both groups at 0 and 1 min, increased at 3rd min and gradually decreased by 30th min. Statistically, significant difference was found between two groups at 1, 3, 5, 10, and 15th min (P < 0.05). Though there was no significant difference in systolic blood pressure, diastolic blood pressure and mean arterial pressure between the two groups, there was no rise in these parameters. Gabapentin produced more sedation than clonidine postoperatively, and few side effects were noted.Conclusion:Both oral clonidine and gabapentin are effective in obtunding pressor response to direct laryngoscopy, clonidine being better in terms of controlling HR. Gabapentin produces more postoperative sedation than clonidine.
Background: Laparoscopic surgeries, including cholecystectomy are being performed on a large scale owing to the improved tissue healing and minimal hospital stay. However the haemodynamic response to pneumoperitoneum could pose a problem in these patients. The primary objective of this study was to evaluate the effectiveness of 1µg/kg intravenous clonidine in suppression of this hemodynamic response. The secondary objective was to assess the postoperative analgesia and sedation.Methods: 60 patients posted for laparoscopic cholecystectomy were divided into two groups. 30 patients received intravenous midazolam 0.03mg/kg and pentazocine 0.3mg/kg and the other 30 received intravenous clonidine 1µg/kg 15 minutes prior induction.Results: Intraoperative mean pulse rate was 90.82±4.81 beats per minute in control group. In clonidine group it was 74.76±9.88 beats per minute (p<0.05 significant). Similarly the mean systolic blood pressure was 137.87±4.89 and 125.79±6.44 respectively (p<0.05-significant). The duration of postoperative analgesia was 334.83±24.65 and 116.05±19.17 minutes respectively (p<0.05).Conclusions: Premedication with intravenous clonidine, has been found to be relatively safe as well as an effective method that provides stable haemodynamics and protection against stress response induced by pneumoperitoneum in patients undergoing laparoscopic cholecystectomy.
Objective: To evaluate the efficacy and safety of PNB001 a CCK-A agonist and CCK-B antagonist, a new chemical entity with anti-inflammatory and immune stimulation properties, along with Standard of Care (SOC) in patients with moderate COVID-19 infection. Design: Multi-center, randomized, parallel group, comparative, open label study. Setting: Two tertiary-care hospitals in India. Participants: Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) within 2 days of randomization, having pneumonia with no signs of severe disease (severe disease means SpO2<=94% on room air), and any two of the following signs or symptoms suggestive of COVID-19: fever, cough, dyspnea, or hypoxia. Interventions: Patients were randomized 1:1 to receive PNB001 at an oral dose of 100 mg three times daily for 14 days with Standard of Care (PNB001+SOC) or only SOC. Main outcome measures: The primary endpoints were mean change in the 8-point WHO Ordinal Scale score from baseline by Day 14 and mortality rate by Day 28. The key secondary endpoints were percentage of patients showing change in clinical status using the ordinal scale, improvement in inflammatory segments in X-ray chest, reduction of days of hospitalization, duration of supplemental oxygen use, days to negative PCR for COVID-19 and change in inflammation markers Interlukin-6 (IL6) and C-reactive protein (CRP) from baseline by Day 14. Results: A total of 40 (20 in PNB 001+SOC arm and 20 in SOC arm) patients were randomized and received treatment. The primary endpoint showed significant clinical improvement from baseline to Day 14 with PNB001+SOC (0.22 Vs 1.12; P=0.0421). One patient in PNB001+SOC arm and two patients in SOC arm died (1 Vs 2; HR: 2.0 [95%CI=0.18, 22.05]; P=0.5637) by Day 28. At the end of the treatment by Day 14, more patients achieved zero ordinal scale in PNB001+SOC arm (17 Vs 12; P=0.0766). In the PNB001+SOC arm, change in mean chest X-ray score showed significant improvement (2.05 Vs 1.16; P=0.0321), and more patients quickly showed complete improvement (10 Vs 7; HR: 1.48 [95%CI=0.64, 3.44]; P=0.4309). In the PNB001+SOC arm, patients needed shorter duration of hospitalization in days (9.45 Vs 9.80) and more patients attained earlier discharge from the hospital (19 Vs 15; P=0.0486) with respect to days. The mean duration of supplemental oxygen requirement in days was shorter (5.45 Vs 7.10) and complete withdrawal from supplemental oxygen was more frequent with PNB001+SOC compared to SOC by Day 14 (17 Vs 13; P=0.1441). All patients in both the arms had negative PCR by the end of the study (18 Vs 17; P=0.6265) by similar time (7.6 Vs 7.0). Exploratory analysis done for IL-6, CRP, Neutrophil-Lymphocyte-Ratio (NLR), Platelet-Lymphocyte-Ratio (PLR) and Erythrocyte Sedimentation Rate (ESR) showed statistically significant reduction by Day 14 demonstrating PNB001's anti-inflammatory and immunomodulatory properties. Lymphocyte and neutrophil counts also improved by Day 14. 11 adverse events (AE) in 8 patients were observed with PNB001+SOC compared to 13 AEs in 10 patients with SOC; none of the AEs in PNB001+SOC arm were related to PNB001. The most common AE were tachycardia and acute respiratory distress syndrome; there were isolated cases of hepatic enzyme elevation and hyperglycemia. Overall, safety profile was similar between PNB001+SOC and SOC arms. Conclusions: PNB001 with standard of care showed significant clinical improvement in moderate COVID-19 patients when compared to standard of care and was well tolerated by moderate COVID-19 patients.
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