Single-dose IV magnesium sulfate to reduce pain after laparoscopic gallbladder removal
Effect of Single Dose Intravenous Magnesium Sulfate on Postoperative Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
PHASE4 · Tata Main Hospital · NCT07328893
We will try a single IV dose of magnesium sulfate to see if adults having elective laparoscopic gallbladder removal need less morphine after surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tata Main Hospital (other) |
| Locations | 2 sites (Jamshedpur, Jharkhand and 1 other locations) |
| Trial ID | NCT07328893 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-arm trial enrolling 106 adults aged 18–65 with ASA physical status I–II who are scheduled for elective laparoscopic cholecystectomy. Participants are randomized to receive a single IV dose of magnesium sulfate (30 mg/kg in 100 ml normal saline) or placebo (normal saline) alongside standard anesthetic care. The primary outcome is total postoperative morphine consumption, with secondary outcomes including pain scores (VAS), time to first rescue analgesia, hemodynamic responses, and adverse events. Data will be compared between groups using descriptive statistics, chi-square tests, and t-tests or Mann–Whitney U-tests as appropriate.
Who should consider this trial
Good fit: Adults aged 18–65 with ASA I–II scheduled for elective laparoscopic cholecystectomy who do not have major organ dysfunction and are not on chronic magnesium or calcium-channel blocker therapy.
Not a fit: Patients with renal, hepatic, or cardiovascular dysfunction (including conduction disorders), BMI >30, obstructive sleep apnea, long-term calcium channel blocker or magnesium use, opioid/analgesic abuse, psychiatric illness, or whose surgery may be converted to open are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, this could reduce the amount of postoperative opioids needed and lower opioid-related side effects after laparoscopic cholecystectomy.
How similar studies have performed: Previous randomized trials and meta-analyses of perioperative IV magnesium have shown modest opioid-sparing effects in various surgical settings, though results have been mixed and depend on dose and context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jamshedpur, Jharkhand and 1 other locations
- Tata Main Hospital — Jamshedpur, Jharkhand, India (RECRUITING)
- Dr.Deb Sanjay Nag — Jamshedpur, Jharkhand, India (RECRUITING)
Study contacts
- Study coordinator: Dr Deb Sanjay Nag, MD
- Email: debsanjay@gmail.com
- Phone: 9431166582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Analgesia, Postoperative