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

NCT ID: NCT06879288

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-02-01

Brief Summary

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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

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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.

Conditions

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Dexmedetomidine Magnesium Sulfate Adjuvants Intraperitoneal Bupivacaine Postoperative Analgesia Elective Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bupivacaine group

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Dexmedetomidine group

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Magnesium group

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

Group Type EXPERIMENTAL

Magnesium sulfate

Intervention Type DRUG

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

Interventions

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Bupivacaine

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Magnesium sulfate

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Maha Mahmoud Rabee El Gazzar

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264MS215/6/23

Identifier Type: -

Identifier Source: org_study_id

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