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Completed

NCT Number: NCT07079514

Effect of Magnesium Sulfate on Hemodynamics on Laparoscopic Cholecystectomy Patients

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.

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Key information

Conditions

Hemodynamics Instability Digestive System Diseases Nausea Neurologic Manifestations PONV in Laparoscopic Cholocystectomies Pain Pain After Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Pneumoperitoneum Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dr Ziauddin Hospital

Karachi, Sindh, 75600, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

normal saline in 100ml piggy bag

Magnesium

Drug

Magnesium Sulphate will be given as doses of 20-50mg/kg in 2 -3 minutes. In order to standardize the dose in every patient we will be using 3g

Other names: MgSo4, Magnesium sulphate

Primary outcomes

  1. Changes in Mean arterial pressures (MAP), Systolic blood pressures (SBP), Diastolic blood pressures (DBP)

    Time frame: 6 months

    Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum, which leads to increased sympathetic activity, elevated blood pressure

  2. Changes in Heart Rate (HR)

    Time frame: 6 months

    Laparoscopic surgeries, such as cholecystectomy, require CO₂ insufflation to create pneumoperitoneum

Secondary outcomes

  1. Pain Scores on the Visual Analog SCALE

    Time frame: 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

Other outcomes

  1. YES/NO questionnaire for Post operative nausea vomiting

    Time frame: 6 months

    post operative nausea vomiting assessment will through yes or no questionnaire

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

Role of Magnesium Sulphate Versus Placebo on Hemodynamic Changes During Pneumoperitoneum During Laparoscopic Procedures

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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