Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT07248358
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efface of Ketamine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy
Sponsor:
Liaquat National Hospital & Medical College
Organization:
Study Overview
Official Title:
The Efface of Ketamine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: