Effect of Magnesium Sulfate on Hemodynamics on Laparoscopic Cholecystectomy Patients

Not Applicable

Completed

• Conditions: Hemodynamics Instability; Pain After Surgery; PONV in Laparoscopic Cholocystectomies
• Interventions: Drug: Placebo; Drug: Magnesium

• Registration Number: NCT07079514
• Lead Sponsor: Ziauddin University

Brief Summary

The goal of this triple blinded randomized control trial is to compare the effect of magnesium sulphate on the hemodynamic response during pneumoperitoneum creation, along with its impact on postoperative pain, opioid consumption, and post operative nausea vomiting (PONV) in ASA I to III patients undergoing laparoscopic cholecystectomy The main question\[s\] it aims to answer is whether the agent Magnesium Sulphate will blunt the increase in the hemodynamic response during peritoneal insufflation, and will it decrease post operative opioids consumption and prevent nausea vomiting in patients undergoing laparoscopic surgeries.

30 were given placebo and 30 were introduced with magnesium sulphate (3mg) 5 mins before insufflation. The hemodynamic such as, mean arterial pressure (MAP,) systolic (SBP) and diastolic blood pressures (DBP), heart rate (HR) were recorded pre operatively and intraoperatively with intervals of 5mins. Pain score was recorded by VAS scaling and post operative nausea vomiting (PONV) with Yes and No in post operative anesthesia unit (PACU) period.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-06
• Primary Completion: 2025-04-21
• Study Completion: 2025-04-21
• Status Verified: 2025-06
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 to 85
• Gender: Male /Female
• ASA status I/II/III
• Patients undergoing elective Laparoscopic cholecystectomy

Exclusion Criteria

• Known Hypermagnesemia
• Known allergy to Magnesium
• Any degree of Heart Block
• Patients on Calcium Channel Blockers
• Known CKD/AKI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Placebo	100ml normal saline is used as placebo
groupB	Magnesium	3g magnesium sulphate

Primary Outcome Measures

Name	Time	Method
Changes in Mean arterial pressures (MAP), Systolic blood pressures (SBP), Diastolic blood pressures (DBP)	6 months	Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum, which leads to increased sympathetic activity, elevated blood pressure
Changes in Heart Rate (HR)	6 months	Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum

Secondary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog SCALE	6 months	magnesium sulfate acts on NMDA receptor and has non opioid pain relieving properties hence we are going to assess whether there's a decrease in post operative pain

Trial Locations

Locations (1)

Dr Ziauddin Hospital; 🇵🇰 Karachi, Sindh, Pakistan