Effect of Magnesium Sulfate on Hemodynamics on Laparoscopic Cholecystectomy Patients

Ziauddin University

Status and phase: Completed; Phase 2; Phase 1

Conditions: PONV in Laparoscopic Cholocystectomies; Pain After Surgery; Hemodynamics Instability

Treatments: Drug: Placebo; Drug: Magnesium

Study type: Interventional

Funder types: Other

Identifiers

NCT07079514

8840724RHANE

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

group A

Placebo Comparator group

Description:

100ml normal saline is used as placebo

Treatment:

Drug: Placebo

groupB

Active Comparator group

Description:

3g magnesium sulphate

Treatment:

Drug: Magnesium