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

NCT06879288 | Completed

• 1 other identifier: 36264MS215/6/23
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Magnesium Sulfate; Adjuvants; Intraperitoneal Bupivacaine; Postoperative Analgesia; Elective Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  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.

  24 hours postoperatively

Secondary Outcomes (4)

• Time to the first rescue analgesia request

  24 hours postoperatively

• Total morphine consumption

  24 hours postoperatively

• Level of sedation

  24 hours postoperatively

• Lenght of hospital stay

  1 week postoperatively

Study Arms (3)

Bupivacaine group

ACTIVE COMPARATOR

Patients received intraperitoneal bupivacaine only at the end of the operations.

Drug: Bupivacaine

Dexmedetomidine group

EXPERIMENTAL

Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations.

Drug: Dexmedetomidine

Magnesium group

EXPERIMENTAL

Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations.

Drug: Magnesium sulfate

Interventions

Bupivacaine DRUG

Patients received intraperitoneal bupivacaine only at the end of the operations.

Bupivacaine group

Dexmedetomidine DRUG

Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations.

Dexmedetomidine group

Magnesium sulfate DRUG

Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations.

Magnesium group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: July 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)