NCT07693621

Brief Summary

Although both dexmedetomidine and magnesium sulphate have been individually evaluated as adjuvants to local anesthetics, direct comparisons between the two agents in intraperitoneal instillation during laparoscopic cholecystectomy remain limited. Understanding their relative efficacy and safety could provide valuable guidance for optimizing perioperative analgesia in these patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
May 2026Jan 2027

Study Start

First participant enrolled

May 3, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 4, 2026

Last Update Submit

July 4, 2026

Conditions

Magnesium SulfateLaparoscopic CholecystectomyDexmedetomidine

Keywords

bupivacainedexmedetomidinecholecystectomy

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain scores (VAS)

    at rest , at movement

    postoperative day 1

  • Quality of recovery

    QoR-15 questionnaire

    postoperative day 1

Secondary Outcomes (3)

  • Total postoperative opioid consumption

    postoperative day 1

  • Time to first analgesic request.

    postoperative day1

  • Incidence of postoperative nausea and vomiting

    postoperative day 1

Study Arms (2)

group 1

EXPERIMENTAL

Bupivacaine 100 mg (20 mL, plain bupivacaine HCl 0.5%) + dexmedetomidine (1 µg/kg).

Other: Bupivacaine 100 mg + dexmedetomidine 1 µg/kg

group 2

ACTIVE COMPARATOR

Bupivacaine 100 mg (20 mL, plain bupivacaine HCl 0.5%) + magnesium sulphate (50 mg/kg).

Other: Bupivacaine 100 mg + magnesium sulphate 50 mg/kg

Interventions

Bupivacaine 100 mg + dexmedetomidine 1 µg/kgOTHER

20 ml bupivacaine + 1 µg/kg dexmedetomidine . The total volume will be adjusted to 50 mL with saline.

Also known as: group 1
group 1
Bupivacaine 100 mg + magnesium sulphate 50 mg/kgOTHER

20 ml bupivacaine + 50 mg/kg magnesium sulphate . The total volume will be adjusted to 50 mL with saline.

Also known as: group 2
group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years
  • ASA physical status I-II
  • scheduled for elective laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

  • Known hypersensitivity to study drugs
  • history of cardiac arrhythmias or conduction abnormalities
  • severe hepatic/renal impairment
  • chronic opioid or analgesic use
  • pregnancy
  • conversion to open surgery
  • drain insertion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (1)

  • Taki-Eldin A, Badawy AE. OUTCOME OF LAPAROSCOPIC CHOLECYSTECTOMY IN PATIENTS WITH GALLSTONE DISEASE AT A SECONDARY LEVEL CARE HOSPITAL. Arq Bras Cir Dig. 2018 Jun 21;31(1):e1347. doi: 10.1590/0102-672020180001e1347.

    PMID: 29947681RESULT

MeSH Terms

Interventions

BupivacaineDexmedetomidineMagnesium Sulfate

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • sarah m elgamal, MD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sarah m elgamal, MD

CONTACT

01005496440sarahelgamal1990@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 4, 2026

First Posted

July 9, 2026

Study Start

May 3, 2026

Primary Completion (Estimated)

November 3, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)