Clinical Trial: COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE ANALGESIA UNDER GENERAL ANAESTHESIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY (Japan)

Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063402) titled 'COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE ANALGESIA UNDER GENERAL ANAESTHESIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - ANANTA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE

Condition: Condition - POSTOPERATIVE PAIN FOLLOWING SURGERY UNDER GENERAL ANAESTHESIA Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the postoperative analgesic effects of intravenous lignocaine and ketamine, with normal saline as a control, in patients undergoing surgery under general anaesthesia. The study aims to assess postoperative pain intensity using Visual Analogue Scale (VAS) scores at specified time intervals, total opioid consumption during the first 24 hours after surgery, and time to first rescue analgesia administration. Secondary objectives include comparing haemodynamic parameters, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, and evaluating postoperative recovery using the modified Aldrete score Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants received intravenous lignocaine 1.5 mg/kg as a bolus dose at induction of general anaesthesia, followed by continuous intravenous infusion of lignocaine 1.5 mg/kg/h during surgery under general anaesthesia Interventions/Control_2 - Participants received intravenous ketamine 0.15 mg/kg as a bolus dose at induction of general anaesthesia, followed by continuous intravenous infusion of ketamine 0.15 mg/kg/h during surgery under general anaesthesia

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients of both sexes. Patients aged 18 to 60 years. Patients belonging to ASA physical status I and II. Patients undergoing elective surgical procedures under general anaesthesia with a duration not exceeding three hours. Patients who provided written informed consent to participate in the study. Key exclusion criteria - Patients with known drug allergy or hypersensitivity to lignocaine or ketamine. Patients with comorbidities including systemic hypertension, cardiac arrhythmias, diabetes mellitus, chronic obstructive pulmonary disease, or coronary artery disease. Patients with hepatic or renal impairment. Patients receiving calcium channel blockers or antihypertensive medications. Patients who refused to provide consent for participation in the study. Target Size - 72

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 04 Month 06 Day Date of IRB - 2024 Year 05 Month 10 Day Anticipated trial start date - 2024 Year 06 Month 03 Day Last follow-up date - 2025 Year 12 Month 02 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072566

Disclaimer: Curated by HT Syndication.