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

NCT07328893 | Recruiting Phase 4 DMC

• 1 other identifier: TP250122626
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Analgesia; Postoperative

Outcome Measures

Primary Outcomes (1)

• Total dose of post-operative morphine consumption.

  Rescue analgesia, in the form of Morphine (3-4 mg), will be administered if a patient's VAS score is ≥ 4.

  24 hours

Secondary Outcomes (2)

• Post operative Pain Scores Pain

  24 hours

• Time to rescue analgesic

  24 hours

Study Arms (2)

MgSO4(Group: M)

EXPERIMENTAL

The Magnesium Sulfate Group (M), receiving 30 mg/kg intravenous magnesium sulfate diluted in 100 ml Normal Saline at the induction of anesthesia,

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

Normal Saline (Group: S)

PLACEBO COMPARATOR

The Placebo Group Group (S) will recieve 100 ml Normal Saline at the induction of anesthesia.

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

Interventions

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

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.

MgSO4(Group: M); Normal Saline (Group: S)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Main Hospital: lead

Study Sites (2)

Tata Main Hospital

Jamshedpur, Jharkhand, 831001, India

RECRUITING

Dr.Deb Sanjay Nag

Jamshedpur, Jharkhand, 831011, India

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Dr Deb Sanjay Nag, MD

CONTACT

9431166582; debsanjay@gmail.com

Himanshu Kumar, DNB

CONTACT

7763807104; himanshu.kumar@tatasteel.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind: not only from participants and administrators, but also from those tasked with analyzing the data after the experiment has concluded. Masking will be done by independent caregivers making the drug or the palcebo (drug) in look alike syringes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Consultant & HOD

Model Details: The central research question revolves around whether a single intravenous dose of magnesium sulfate can effectively reduce postoperative analgesic consumption in this patient population.

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: December 27, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)