NCT07425444

Brief Summary

Aims of this study are to compare the effectiveness of dexmedetomidine versus fentanyl-midazolam in attenuating hemodynamic stress response during laparoscopic cholecystectomy (mainly HR). And to assess the recovery profile, the pain and opioid requirements, the sedation profile, and any adverse events during the first 24 hrs postoperatively

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
10mo left

Started Feb 2026

Status
not yet 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 Progress26%
Feb 2026Apr 2027

Study Start

First participant enrolled

February 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 20, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

February 7, 2026

Last Update Submit

February 19, 2026

Conditions

Laparoscopic Cholecystectomy Surgery

Keywords

stress response

Outcome Measures

Primary Outcomes (1)

  • Hemodynamics

    Hemodynamics mainly HR

    During procedure

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL
Drug: Dexmedetomidine

Fentanyl-Midazolam Group

ACTIVE COMPARATOR
Drug: Fentanyl- midazolam

Interventions

DexmedetomidineDRUG

investigator will give Loading dose 1 mcg/kg IV over 10 min, followed by infusion 0.5 mcg/kg/h until pneumoperitoneum established

Dexmedetomidine Group
Fentanyl- midazolamDRUG

Investigator will inject Fentanyl 2 mcg/kg IV + Midazolam 0.05 mg/kg IV before induction.

Fentanyl-Midazolam Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I - II.

You may not qualify if:

  • Known allergy to study drugs.
  • Uncontrolled, non-correctable comorbidities (hepatic, renal or cardiac such as hypertension \& Arrhythmia ).
  • History of psychiatric illness or substance abuse.
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Kum CK, Goh PMY, Isaac JR, et al. Laparoscopic cholecystec tomy for acute cholecystitis. Br J Surg 1994; 81:1651-1654.

    RESULT

  • Bass EB, Pitt HA, Lillemoe KD. Cost-effectiveness of laparoscopic cholecystectomy versus open cholecystectomy. Am J Surg 1993; 165:466-471.

    RESULT

  • GARDOCKIJF, YELNOSKYJ. A study of some of the pharmacologic actions of fentanyl citrate. Toxicology and applied Pharmacology 1964; 6: 48-62.

    RESULT

  • Kohno T, Kumamoto E, Baba H, et al. Actions of midazolam on GABAergic transmission in substantia gelatinosa neurons of adult rat spinal cord slices. Anesthesiology 2000; 92: 507-515

    RESULT

  • Kosugi T, Mizuta K, Fujita T, Nakashima M, Kumamoto E. High concentrations of dexmedetomidine inhibit compound action potentials in frog sciatic nerves without alpha(2) adrenoceptor activation. Br J Pharmacol 2010;160: 1662-1676.

    RESULT

  • SMITHJE, KINGMJ, YANNY HF, POTTINGER KA, POMIRSKA MB. Effect of fentanyl on the circulatory responses to orotracheal fibreoptic intubation. Anaesthesia 1992;47: 20-3.

    RESULT

  • Bucx MJL, VANGEELRTM, SCHECKPAE, STIJNEN T. Cardiovascular effects of forces applied during laryngoscopy. The importance of tracheal intubation. Anaesthesia 1992; 47:

    RESULT

  • WEATHERILL D, SPENCE AA. Anaesthesia and disorders of the adrenal cortex. British Journal of Anaesthesia 1984; 56: 741-9.

    RESULT

  • DERBYSHIRE DR, CHMIELEWSKI A, FELLD, VATERM, ACHOLA KJ, SMITHG. Plasma catecholamine responses to tracheal intubation. British Journal of Anaesthesia 1983; 55: 85540

    RESULT

  • SIEDLECKI J. Disturbances in the function of cardiovascular system in patients following endotracheal intubation and attempts to their prevention by pharmacological blockade of the sympathetic system. Anaesthesia, Resuscitation and Intensive Therapy 1975, 3: 107-23.

    RESULT

MeSH Terms

Conditions

Fractures, Stress

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Anas Ahmed Abd elmoaty, resident doctor

CONTACT

+201006318654anasa1@yahoo.com

Obey mohamed elhassan Shaker Osman, prof

CONTACT

+201143311373Obeywafa@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 20, 2026

Record last verified: 2025-12