A Phase 4 interventional study of Dexmedetomidine and Fentanyl- midazolam in Laparoscopic Cholecystectomy Surgery, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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
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).
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)
168 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 134 interventional studies indexed under Fractures, Stress.
Browse Fractures, Stress studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: Dexmedetomidine
Drug: Fentanyl- midazolam
investigator will give Loading dose 1 mcg/kg IV over 10 min, followed by infusion 0.5 mcg/kg/h until pneumoperitoneum established
Investigator will inject Fentanyl 2 mcg/kg IV + Midazolam 0.05 mg/kg IV before induction.
Hemodynamics
Hemodynamics mainly HR
Time frame: During procedure
No study locations are listed for this record.
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Assiut University