OUTCOME OF LAPAROSCOPIC CHOLECYSTECTOMY IN PATIENTS WITH GALLSTONE DISEASE AT A SECONDARY LEVEL CARE HOSPITAL.
Ahmed Taki-Eldin, Abd-Elnaser Badawy
https://pubmed.ncbi.nlm.nih.gov/29947681/Actively Recruiting
Led by Alexandria University · Updated on 2026-07-09
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are comparing two adjuvants, dexmedetomidine and magnesium sulphate, added to bupivacaine for pain relief during laparoscopic cholecystectomy, a common minimally invasive gallbladder surgery. While both agents have shown potential to improve analgesia, direct comparisons of their effects when delivered intraperitoneally during this surgery are limited. This study aims to assess their relative effectiveness and safety to help optimize postoperative pain management. Participants will receive intraperitoneal instillation of bupivacaine combined either with dexmedetomidine or magnesium sulphate at the end of surgery before trocar removal. Both groups receive a total volume of 50 mL adjusted with saline. Standard anesthesia and perioperative care will be provided, including intravenous medications and monitoring. The study is randomized, double-blind, and controlled, with two groups receiving either bupivacaine plus dexmedetomidine or bupivacaine plus magnesium sulphate. During the trial, patients will be closely monitored for pain using the Visual Analog Scale at multiple time points up to 24 hours after surgery, quality of recovery via questionnaire, opioid consumption, time to first analgesic request, incidence of nausea and vomiting, and vital signs. Safety and adverse events related to the study drugs will also be recorded. The study is conducted at a tertiary hospital with thorough preoperative evaluation and postoperative pain management, aiming for comprehensive assessment within the first postoperative day.
CONDITIONS
Intraperitoneal Dexmedetomidine Versus Magnesium as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy
S
sarah m elgamal, MD
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Alexandria University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (preoperative evaluation)
Duration - Surgery day
Participants receive standard anesthesia and intraperitoneal instillation of bupivacaine combined with either dexmedetomidine or magnesium sulphate during laparoscopic cholecystectomy.
1 surgical visit
Duration - 24 hours after surgery
Participants are monitored for pain, recovery quality, opioid use, nausea, and vital signs up to 24 hours after surgery.
Multiple assessments during hospital stay
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Ahmed Taki-Eldin, Abd-Elnaser Badawy
https://pubmed.ncbi.nlm.nih.gov/29947681/Alexandria University
Lead Sponsor