The Efface of Ketamine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy

Liaquat National Hospital & Medical College

Status and phase: Completed; Phase 1

Conditions: Laparoscopic Cholecystectomy Surgery; Postoperative Pain Management

Treatments: Drug: IV 2mg of Magnesium Sulphate; Drug: IV ketamine 0.5 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT07248358

1096-2024-LNH-ERC

Details and patient eligibility

About

This prospective interventional study was conducted at Liaquat National Hospital and Medical College to compare the postoperative analgesic effects of ketamine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. A total of 78 ASA I-II patients were included and randomly allocated into two equal groups (39 patients in each group) using a sealed-envelope technique. One group received ketamine, while the other received magnesium sulphate, following a standardized intraoperative anesthesia protocol. All patients were provided routine postoperative medications according to institutional practice. Pain scores were recorded using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery. The objective of this study was to determine which drug offered better postoperative pain relief, thereby contributing to improved analgesic strategies for patients undergoing laparoscopic cholecystectomy.

Full description

Effective postoperative pain control plays a crucial role in accelerating recovery, minimizing physiological stress, and improving patient satisfaction after laparoscopic cholecystectomy. This prospective interventional study was carried out in the Department of Anesthesiology at Liaquat National Hospital and Medical College to evaluate and compare the analgesic benefits of intravenous ketamine and magnesium sulphate in adults undergoing elective laparoscopic cholecystectomy.

A total of 78 patients classified as ASA I and II with uncomplicated symptomatic gallstones were recruited after obtaining ethical approval and written informed consent. The study was conducted in a double-blinded, participants were randomized into two groups through a sealed-envelope technique: Group K (n = 39) received ketamine, while Group M (n = 39) received magnesium sulphate adding both of the intervention were active drug agent. Patients with ASA III-V, chronic pain disorders, psychiatric illness, pregnancy or breastfeeding status, significant hepatic, renal, or cardiac impairment, or recent use of opioids or NSAIDs were excluded.

All enrolled individuals underwent routine preoperative evaluation and overnight fasting. General anesthesia was induced with propofol and atracurium and maintained with isoflurane, with continuous monitoring of vital parameters including heart rate, non-invasive blood pressure, ECG, oxygen saturation, and end-tidal CO₂. At the completion of surgery, neuromuscular blockade was reversed with neostigmine. Standard postoperative medications consisted of intravenous diclofenac sodium every 8 hours for background analgesia, along with ondansetron for nausea prophylaxis.

Postoperative pain levels were documented using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours following surgery. Patients who experienced significant pain were administered intravenous Kinz 5 mg as rescue analgesia, with administration times recorded by nursing personnel.

This study offered meaningful evidence regarding the comparative analgesic performance of ketamine and magnesium sulphate in the early postoperative period after laparoscopic cholecystectomy. The findings support their potential utility as part of a multimodal analgesic approach aimed at improving patient comfort and enhancing postoperative recovery.

Enrollment: 78 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA physical status I-II. Elective laparoscopic cholecystectomy planned under general anesthesia. Normal baseline renal, hepatic, and coagulation profile. Able to give informed consent and communicate pain scores. Negative pregnancy test for women of childbearing age.

Exclusion criteria

• Allergy or hypersensitivity to ketamine, magnesium sulphate, or related drugs. History of psychiatric illness or substance abuse. Chronic use of opioids, benzodiazepines, or MAO inhibitors. Pregnant or breastfeeding women. Chronic pain disorders or use of analgesics within 7 days pre-op. Major hepatic, renal, or cardiovascular dysfunction. History of myopathy or seizure disorders. Patients with atrioventricular block or on calcium-channel blockers. Conversion to open cholecystectomy during surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups

Ketamine Group

Active Comparator group

Description:

The ketamine dose was prepared at 0.5 mg/kg of body weight, diluted with normal saline to make a total volume of 10 mL, and administered intravenously as a single bolus during anesthesia reversal after the surgery was completed.

Treatment:

Drug: IV ketamine 0.5 mg/kg

Magnesium Sulphate

Active Comparator group

Description:

The magnesium sulfate dose was prepared as 2 mg, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a single stat dose at the time of anesthesia reversal after completion of surgery.

Treatment:

Drug: IV 2mg of Magnesium Sulphate