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

NCT07248358 | Completed Phase 1

• 1 other identifier: 1096-2024-LNH-ERC
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Cholecystectomy Surgery; Postoperative Pain Management

Keywords

ketamine; magnesium sulphate; Laparoscopic Cholecystectomy; Pain; Postoperative Pain; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score

  Postoperative pain was evaluated using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery to compare the efficacy and duration of analgesia between the ketamine and lidocaine groups. These time points were chosen to capture both early and late pain responses within the first 24 hours of recovery.

  Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

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.

Drug: IV ketamine 0.5 mg/kg

Magnesium Sulphate

ACTIVE COMPARATOR

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.

Drug: IV 2mg of Magnesium Sulphate

Interventions

IV ketamine 0.5 mg/kg DRUG

Here is a rewritten and unbolded version of your paragraph: \--- Patients in the ketamine group were given intravenous ketamine at a dose of 0.5 mg/kg of body weight, diluted with normal saline to a total volume of 10 mL. The solution was administered as a single intravenous injection at the time of anesthesia reversal, immediately after completion of laparoscopic cholecystectomy. The drug was given under aseptic conditions by an anesthetist who was unaware of group allocation. All patients received standard postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline analgesia and intravenous ondansetron 4 mg for nausea prophylaxis. Postoperative pain was assessed at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients reporting significant pain were given intravenous Kinz 5 mg as rescue analgesia, with the timing of administration recorded.

Ketamine Group

IV 2mg of Magnesium Sulphate DRUG

Patients in the magnesium sulfate group received 2 mg of the drug, which was 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 following completion of laparoscopic cholecystectomy. The injection was performed under aseptic conditions by an anesthetist who was blinded to group assignment. All participants received routine postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline pain control and intravenous ondansetron 4 mg to prevent nausea. Postoperative pain intensity was measured using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours. Patients experiencing significant pain were given intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was recorded for documentation.

Magnesium Sulphate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Anesthesiology Department Liaquat National Hospital and Medical College

Karachi, Sindh, 78400, Pakistan

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Ketamine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ali Asgher, Mbbs, FCPS

  Liaquat National Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mustafa Hussain Imam

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: June 15, 2023
• Primary Completion: September 15, 2025
• Study Completion: October 20, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)