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DO WE REALLY NEED OPIOIDS? - A STUDY DONE IN CHOLECYSTECTOMY PATIENTS.

COMPARISON OF OPIOID FREE ANAESTHESIA AND CONVENTIONAL GENERAL ANAESTHESIA IN PATIENTS UNDERGOING LAPROSCOPIC CHOLECYSTECTOMY â?? A PROSPECTIVE RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053717
Enrollment
70
Registered
2023-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: OPIOID FREE ANAESTHESIA: premedication with lidocaine 1.5 mg/ kg IV, magnesium sulfate 40 mg/kg (in 100 ml of saline without exceeding 2.5 g), ketamine 25 mg IV and dexamethasone 0.1 mg

Sponsors

NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL
Lead Sponsor
NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade I and II 2. BMI -18-25 3. Undergoing laparoscopic cholecystectomy 4. Written informed consent

Exclusion criteria

Exclusion criteria: • history of allergy to any drug used for OFA or CGA; • history of alcohol, opioid or drug abuse; • chronic pain • psychiatric illness; • patients undergoing surgery with planned regional anesthesia, • patients with iatrogenic surgical complications such as bowel, ureter or bladder injuries. • Duration of surgery exceeding 90 minutes. • pregnancy

Design outcomes

Primary

MeasureTime frame
the intraoperative need to administer opioids for adequate intraoperative analgesia.Timepoint: 1) INTRAOPERATIVE 2) POSTOPERATIVE TILL 48 HRS AFTER THE SURGERY

Secondary

MeasureTime frame
1. Occurrence of intra-operative complications e.g. hypotension, hypertension, tachycardia and bradycardia. 2. Mean alveolar concentration (MAC in %) of isoflurane used in both groups. 3. Pain intensity (assessed using the Numerical Rating scale) 4. Need for opioids for pain relief within the first 48 h of surgery; 5. Patient satisfaction (assessed on the Quality of Recovery-40 [QoR-40] questionnaire) at 24 h and 48 h postoperation Timepoint: intra-operative & post operative period (24 & 48 hrs)

Countries

India

Contacts

Public ContactDR SHWETA DHIMAN

NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL

13shweta1990@gmail.com9650474249

Outcome results

None listed

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