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临床试验/NCT07425444
NCT07425444尚未招募4 期

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

Assiut University0 个研究点目标入组 50 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
50
主要终点
Hemodynamics

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Dexmedetomidine Group

Experimental

干预措施: Dexmedetomidine (Drug)

Fentanyl-Midazolam Group

Active Comparator

干预措施: Fentanyl- midazolam (Drug)

结局指标

主要结局

Hemodynamics

时间窗: During procedure

Hemodynamics mainly HR

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anas Ahmed Abd Elmoaty

doctor

Assiut University

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