Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia After Elective Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Dexmedetomidine; Magnesium Sulfate; Adjuvants; Intraperitoneal Bupivacaine; Postoperative Analgesia; Elective Laparoscopic Cholecystectomy
• Interventions: Drug: Bupivacaine; Drug: Dexmedetomidine; Drug: Magnesium sulfate

• Registration Number: NCT06879288
• Lead Sponsor: Tanta University

Brief Summary

This study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy.

Detailed Description

Pain after laparoscopy is less intense than after laparotomy, but laparoscopy is not pain free and analgesia after this type of surgery is inadequately studied. Intraperitoneal (IP) instillation/nebulization of local anesthetics has been used as a method for reducing postoperative pain and opioid use following laparoscopy through acting on visceral nociceptors of the peritoneum.

Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. It is available mixed with a small amount of epinephrine to increase the duration of its action. It typically begins working within 15 minutes and lasts for 2 to 8 hours.

Dexmedetomidine is a selective alpha-2 (α2) adrenergic agonist known to have analgesic and sedative characteristics that can augment the duration of action of local anesthetics.

Magnesium is an N-methyl-D-aspartate receptor antagonist in addition to its effects on calcium influx. The anti-inflammatory and opioid-sparing effects make it a popular component of opioid free anaesthesia. It is extensively used for perioperative analgesia in a dose of 30- to 50-mg/kg intravascular bolus followed by a 10- to 15-mg/kg/h infusion.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Age from 21 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) class I-III.
• Scheduled to undergo elective laparoscopic cholecystectomy.

Exclusion Criteria

• Patient refusal.
• Body mass index ≥40.
• Allergy to the study drugs.
• Advanced cardiac, renal and hepatic diseases.
• Patients with peritoneal drain or peritoneal wash after surgery.
• Uncooperative patients.
• Chronic pain medications.
• Hypomagnesaemia or hypermagnesaemia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine group	Bupivacaine	Patients received intraperitoneal bupivacaine only at the end of the operations.
Dexmedetomidine group	Dexmedetomidine	Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations.
Magnesium group	Magnesium sulfate	Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations.

Primary Outcome Measures

Name	Time	Method
Degree of pain	24 hours postoperatively	Degree of pain was assessed using the numerical rating score (NRS) (from 0 = no pain, to 10 = the most severe pain).NRS was assessed at 1, 2, 4, 8, 16, and 24 hours postoperative.

Secondary Outcome Measures

Name	Time	Method
Time to the first rescue analgesia request	24 hours postoperatively	Time to the first rescue analgesia request (time from the end of surgery till first dose of morphine administrated)
Total morphine consumption	24 hours postoperatively	If Numerical rating score (NRS)-S \>4, IV 3 mg morphine was given as a rescue analgesia.
Level of sedation	24 hours postoperatively	Level of sedation using Ramsey scale at 1, 2, 4, 8, 16, and 24 hours postoperative from 1 to 6: 1. Patient is anxious and agitated.; 2. Patient is co-operative and oriented.; 3. Patient responds to commands only.; 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.; 5. Patient exhibits sluggish response to light glabellar tap or loud auditory stimulus.; 6. Patient exhibits no response.
Lenght of hospital stay	1 week postoperatively	Length of hospital stay was recorded from admission till discharge from hospital.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt