Comparison of IV dexmedetomidine and lidocaine for analgesic (painkiller) requirement in patients undergoing laparoscopic surgeries

Not yet recruiting

• Conditions: Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis,

• Registration Number: CTRI/2021/04/032968
• Lead Sponsor: Shri Ram Murti Smarak Institute of Medical Sciences

Brief Summary

This prospective randomized double blinded study will carried out on 93 patients in the age group of 18 to 60 yrs of either sex ASA physical status I and II who will be undergoing elective laproscopic surgery. The patients will be divided into three groups which will recieve  intravenous dexmedetomidine  lignocaine and normal saline. The primary outcome of the study is to compare the analgesic effects of intraoperative lignocaine and dexmedetomidine infusion on intraoperative and immediate post operative opioid consumption. The secondary outcome will include hemodynamics and incidence of adverse effects if any

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-19
• Study Start: 2021-04-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• A total of 93 patients aged 18-60 yrs.
• of either sex with ASA physical status I/II undergoing elective laparoscopic surgeries will be enrolled in the study.

Exclusion Criteria

patient refusal, hypersensitivity to the drugs being evaluated, Body Mass Index (BMI) more than 40 kg/m2, pregnancy, significant comorbid conditions like uncontrolled hypertension, congestive heart failure, myocardial infarction in the past 6 months, heart block, fixed cardiac output lesions, chronic liver or kidney illnesses and chronic use of opioids/opioid addiction, steroids, or inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders, patients requiring inotropes or antihypertensive medications intraoperatively.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of our study is to compare the analgesic effects of intraoperative lidocaine and dexmedetomidine infusion on intraoperative and immediate postoperative opioid consumption in patients undergoing laparoscopic surgeries and assessing the VAS at predetermined points i.e., immediately after tracheal extubation, 15 min, 30 min and then hourly until the first rescue analgesic. Mean and cumulative VAS scores and sedation scores shall be compared between the three groups.	immediately after tracheal extubation, 15 min, 30 min and hourly until the first rescue analgesic

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures include analysing intraoperative hemodynamic profile (heart rate and mean arterial pressure) and incidence of adverse effects including intraoperative and postoperative hemodynamic changes, post-operative constipation, sedation, pruritus, PONV and analyzing recovery profile (by comparing RASS at predetermined end points	At baseline(0), induction, tracheal-intubation, before pneumoperitoneum, 15-minute intervals, end-surgery in both groups, immediately after tracheal extubation, 15 min ,30 min, and hourly till RASS score zero.

Trial Locations

Locations (1)

Shri Ram Murti Smarak Institute Of Medical Sciences; 🇮🇳 Bareilly, UTTAR PRADESH, India

Shri Ram Murti Smarak Institute Of Medical Sciences

🇮🇳Bareilly, UTTAR PRADESH, India

Dr Ashita Mowar

Principal investigator

9568578724

drash.royals@gmail.com