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Clinical Trials in India / NCT07328893
Recruiting Phase 4

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

NCT07328893 · tracked via the Priya Life Science India tracker
Sponsor
Tata Main Hospital
Phase
Phase 4
Started
2025-12-27
Last updated
2026-01-09

Condition(s) studied

Analgesia; Postoperative

Investigational drug(s) / intervention(s)

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

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: Age - 18 - 65 years, either sex American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective laparoscopic cholecystectomy Exclusion Criteria: 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Tata Main Hospital Jamshedpur Jharkhand Recruiting
Dr.Deb Sanjay Nag Jamshedpur Jharkhand Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07328893 on ClinicalTrials.gov ↗ ← All trials in India