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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

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

Locations
Other Locations
India
Dr.Deb Sanjay Nag
RECRUITING
Jamshedpur
Tata Main Hospital
RECRUITING
Jamshedpur
Contact Information
Primary
Dr Deb Sanjay Nag, MD
debsanjay@gmail.com
9431166582
Backup
Himanshu Kumar, DNB
himanshu.kumar@tatasteel.com
7763807104
Time Frame
Start Date: 2025-12-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 106
Treatments
Experimental: MgSO4(Group: M)
The Magnesium Sulfate Group (M), receiving 30 mg/kg intravenous magnesium sulfate diluted in 100 ml Normal Saline at the induction of anesthesia,
Placebo_comparator: Normal Saline (Group: S)
The Placebo Group Group (S) will recieve 100 ml Normal Saline at the induction of anesthesia.
Related Therapeutic Areas
Sponsors
Leads: Tata Main Hospital

This content was sourced from clinicaltrials.gov