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

A Randomized controlled trial to compare the postoperative analgesia and haemodynamic response between Opioid Free Anaesthesia regimen(OFA) and standard opioid anaesthesia technique among patients undergoing laparoscopic non cardiac surgeries. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060681

Enrollment

120

Registered

2023-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: DEXMEDETOMIDINE + KETAMINE + LIGNOCAINE SOLUTION: a premixed solution of 50 mcg dexmedetomidine, 50 mg ketamine and 500 mg intravenous lignocaine with 0.9% normal saline to constitute

Eligibility

Inclusion criteria

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

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 Pregnancy Patients with Seizure disorder Patients with psychiatric illnesses or on antipsychotic medications Patients with Cardiac arrhythmias /AV block/ Bradycardia ( <50/min)

Design outcomes

Primary

Measure	Time frame
Intraoperative haemodynamic stability (heart rate,blood pressure) post operative analgesia using Numerical Rating ScoreTimepoint: Intraoperative haemodynamic stability (heart rate,blood pressure) at 0,3,6,12,24 hours	—

Secondary

Measure	Time frame
gastrointestinal recovery after surgery,haemodynamic instability,postoperative nausea and vomiting, respiratory depression,pruritusTimepoint: 24hours;quality of Recovery-15Timepoint: 24 hours;Ramsay sedation scoreTimepoint: 24hours	—

Countries

India

Contacts

Public ContactDrBlesita T Jose

HOD, DEPARTMENT OF ANAESTHESIOLOGY

hod.anaesthesiology@bcmch.edu.in9888500240

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026