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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTata Main Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: MgSO4(Group: M)Experimental treatment 1 intervention
Group B: Normal Saline (Group: S)Placebo comparator 1 intervention

Trial outcomes

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.

Time frame
24 hours

Secondary outcomes

1

Post operative Pain Scores Pain

Visual Analogue Scale

Time frame
24 hours
2

Time to rescue analgesic

Time after the surgery when the patient asks for rescue analgesic or the patient's VAS score is ≥ 4.

Time frame
24 hours

Other outcomes

Sponsors and contacts

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