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RECRUITING
NCT07328893
PHASE4

Effect of Single Dose Intravenous Magnesium Sulfate on Postoperative Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy

Sponsor: Tata Main Hospital

View on ClinicalTrials.gov

Summary

This study describes a randomized controlled trial designed to evaluate the impact of a single intravenous dose of magnesium sulfate on postoperative analgesic consumption in patients undergoing laparoscopic cholecystectomy. The primary aim is to determine if magnesium sulfate can reduce postoperative morphine usage and its associated side effects. The study will involve 106 patients (53 per arm), aged 18-65, classified as ASA physical status I or II, who are scheduled for elective laparoscopic cholecystectomy. Participants will be randomly assigned to receive either 30 mg/kg intravenous magnesium sulfate or a placebo (normal saline), alongside standard anesthetic care. Secondary outcomes include pain scores, the time until rescue analgesia is needed, and the monitoring of hemodynamic responses and potential adverse events. Statistical analysis will utilize descriptive statistics, chi-square tests, and t-tests or Mann-Whitney U-tests to compare the two groups.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2025-12-27

Completion Date

2026-12-31

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DRUG

Magnesium Sulfate 30 mg/kg intravenous diluted in 100 ml Normal Saline.

Patients will be randomly assigned to one of two groups: the Magnesium Sulfate Group (M), receiving 30 mg/kg intravenous magnesium sulfate diluted in 100 ml Normal Saline at the induction of anesthesia, or the Normal Saline Group (S), receiving an equivalent volume of Normal Saline. Both groups will also receive standard multimodal analgesia with intravenous Diclofenac (75 mg) and Paracetamol (1 gm) at the time of port closure.

Locations (2)

Tata Main Hospital

Jamshedpur, Jharkhand, India

Dr.Deb Sanjay Nag

Jamshedpur, Jharkhand, India