RecruitingPhase 4NCT07328893

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

Sponsor

Tata Main Hospital

Enrollment

106 participants

Start Date

Dec 27, 2025

Study Type

INTERVENTIONAL

Conditions

Analgesia, Postoperative

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

Age - 18 - 65 years, either sex American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective laparoscopic cholecystectomy

Exclusion Criteria1

Patient refusal BMI > 30 kg/m² OSA Renal, hepatic or cardiovascular dysfunction including cardiac conduction disorders Those on long term calcium channel blockers or receiving magnesium supplements Opioid or analgesic abuse Psychiatric illness Surgical duration < 1 h \& > 3 h Lap converted to open

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Interventions

DRUGMagnesium 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.