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Clinical Trials/NCT07425444
NCT07425444
Not yet recruiting
Phase 4

Dexmedetomidine Versus Fentanyl-Midazolam Combination to Attenuate the Stress Response in Laparoscopic Cholecystectomy

Assiut University0 sites50 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Enrollment
50
Primary Endpoint
Hemodynamics

Overview

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

Detailed Description

Induction of general anesthesia, direct laryngoscopy and tracheal intubation induce marked cardiovascular changes as well as autonomic reflex activity. Although the responses of blood pressure and heart rate are short lived, they might have detrimental effects in high-risk patients, especially those with cardiovascular disease (1). These cardiovascular responses are associated with increased plasma levels of catecholamines (2). The main reason for the intubation induced hypertension seems to be a release of noradrenaline and, to a lesser extent, of adrenaline. In addition, increased levels of adrenocorticotrophic hormone (ACTH) and dopamine have also been reported (3).

A variety of factors have been shown to have an effect on this stress response: the choice and dosages of premedication and induction agents (4), the skill of the operator, and probably the technique being used. Numerous studies have demonstrated an increased stress response during direct laryngoscopy, fibreoptic intubation and insertion of the laryngeal mask (5).

  • Dexmedetomidine is an Alpha 2 adrenoreceptors agonists may exert its analgesic effect through hyperpolarization of the non-adrenergic neurons which leads to depression of neuronal firing in the locus ceruleous together with suppression of the release of norepinephrine because of the stimulation of the central adrenergic receptors which produces a hypnotic effect without ventilatory depression (6).
  • Midazolam is the benzodiazepine with the shortest half-life. It produces sedation and amnesia by acting on the γ-aminobutyric acid type-A receptors; additionally, its combined application in peripheral nerve blocks can increase the convulsive threshold of local anesthetics. It should be noted that GABA enhanced in amplitude by midazolam resulting in inhabitation of projection neurons and antinociception (7).

Fentanyl citrate is an opioid strong analgesic that is particularly well suited for use in anesthesia because of its high potency, rapid onset and short duration of action, absence of emetic activity, and minimal hypotensive activity after intravenous administration. As with other morphine-like analgesics. (8).

Laparoscopic cholecystectomy has increasingly been accepted as the procedure of choice for treatment of symptomatic gallstones and chronic cholecystitis (9). Its role and its timing in the management of acute cholecystitis, however remain controversial. The potential hazard of severe complications as a result of distorted anatomy caused by acute inflammation is a major concern (10)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Dexmedetomidine Group

Experimental

Intervention: Dexmedetomidine (Drug)

Fentanyl-Midazolam Group

Active Comparator

Intervention: Fentanyl- midazolam (Drug)

Outcomes

Primary Outcomes

Hemodynamics

Time Frame: During procedure

Hemodynamics mainly HR

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anas Ahmed Abd Elmoaty

doctor

Assiut University

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