A clinical trial to study the effect of two regimen, opioid and opioid free anaesthesia regimen in patients undergoing laparoscopic surgeries.

Phase 2/3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/12/060681

Lead Sponsor: DrAshu Sara Mathai

Brief Summary: This study is Randomized controlled single centre trial to compare the intraoperative haemodynamic stability, Postoperative analgesia and post operative adverse effects in terms of nausea and vomiting, sedation, respiratory depression, pruritis, ileus, heamodynamic instability of an opioid free anaesthesia regimen versus standard opioid based anaesthesia regimen in patients undergoing non cardiac laparoscopic surgeries.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

American society of anaesthesiologist (ASA) classification I,II,III Patients undergoing elective, laparoscopic, non cardiac surgeries of less than 4 hours duration.

Exclusion Criteria

Patients who refuse consent/lack the capacity to give consent Patient with known allergy to the study drugs used Patient with co-existing liver or renal disease Patients undergoing conversion to open surgical technique Patients with preoperative uncontrolled hypertension (Preoperative BP>190/110 mmhg) or hypotension (MAP<65 mmhg) Pregnancy Patients with Seizure disorder Patients with psychiatric illnesses or on antipsychotic medications Patients with Cardiac arrhythmias /AV block/ Bradycardia (<50/min).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative haemodynamic stability (heart rate,blood pressure)	Intraoperative haemodynamic stability (heart rate,blood pressure) \| at 0,3,6,12,24 hours
post operative analgesia using Numerical Rating Score	Intraoperative haemodynamic stability (heart rate,blood pressure) \| at 0,3,6,12,24 hours

Secondary Outcome Measures

Name	Time	Method
Ramsay sedation score	24hours
quality of Recovery-15	24 hours
gastrointestinal recovery after surgery,haemodynamic instability,postoperative nausea and vomiting, respiratory depression,pruritus	24hours

Trial Locations

Locations (1): Believers church medical college hospital Thiruvalla
🇮🇳
Pathanamthitta, KERALA, India
Believers church medical college hospital Thiruvalla
🇮🇳Pathanamthitta, KERALA, India
DR Blesita T jose
Principal investigator
8943186007
blesitatjose@gmail.com