Effect of Single Dose Intravenous Magnesium Sulfate on Postoperative Analgesic Consumption in Pat… (NCT07328893) | Clinical Trial Compass
RecruitingPhase 4
Effect of Single Dose Intravenous Magnesium Sulfate on Postoperative Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
India106 participantsStarted 2025-12-27
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total dose of post-operative morphine consumption.