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General anaesthesia with and without opioids for laparoscopic cholecystectomy patients.

Evaluation of an Opioid Free anaesthesia protocol in comparison with Traditional Anaesthesia practice in patients undergoing Laparoscopic Cholecystectomy: A Randomized Control Trial. - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/059145
Enrollment
160
Registered
2023-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Opioid free anaesthesia: General anaesthesia will be given to laparoscopic cholecystectomy patients without the use of opioids and the total duration of intervention will be 24 hours af

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged >18 years of all sexes, American society of anaesthesiology (ASA) grade I & II, undergoing laparoscopic cholecystectomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients refusing to consent for this study 2. Patients with chronic cardiovascular diseases (i.e., COPD, IHD, arrythmias etc.) 3. Patients with thoraco-lumbar spine pathology, unsuitable to epidural insertion. 4. Patients with allergy to local anaesthetics 5. Opioid dependent patients.

Design outcomes

Primary

MeasureTime frame
Stress response to intubationTimepoint: change in heart rate from before to 1 minutes after intubation in 2 groups

Secondary

MeasureTime frame
Change in systolic BPTimepoint: 1 minutes after intubation;Change in HR and BPTimepoint: 1 minutes after trocar insertion;Post operative pain (NRS score)Timepoint: immediate post op, 1 hr, 6 hr and 24 hr after extubation;Incidence of post-operative nausea and vomitingTimepoint: first 24 hrs after surgery;Patient satisfaction score-QoR 15 scoreTimepoint: on day 1 and on the day of discharge;Duration from surgery to mobilizationTimepoint: 2-3 days;Duration from surgery to dischargeTimepoint: Till discharge;incidence of complications like pruritus, constipationTimepoint: first 24 hours post op

Countries

India

Contacts

Public ContactDeepak Singla

All India Institute of Medical Sciences, Rishikesh

deepak10.4u@gmail.com9068504999

Outcome results

None listed

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