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临床试验/NCT07165483
NCT07165483招募中不适用

Do Increasing Preoperative Timing of Single Dexmedetomidine Dose Have an Effect on Stress Response of Laryngoscopy and Intubation? A Randomized Controlled Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年9月11日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Mean arterial pressure

研究概览

简要总结

This study aims to evaluate the effect of increasing preoperative timing of single dexmedetomidine on the stress response of laryngoscopy and intubation.

详细描述

Maintaining hemodynamic stability during surgery is one of the most important tasks because good anesthesia increases the success rate of surgery and improves postoperative prognosis.

Dexmedetomidine, a potent α2-adrenoreceptor agonist, produces not only a sedative-hypnotic effect, but in situations involving cardiac risk, it also produces analgesic effects and an autonomic blocking effect, by acting on a single type of receptor.

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, Outcomes Assessor)

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

排除标准

  • Severe cardiovascular problems.
  • Respiratory disorders.
  • Diabetes.
  • Hypertension.
  • Allergic reaction to study drugs.
  • Patients on antihypertensive medication (α-methyldopa, clonidine, or other α2-adrenergic agonists)
  • Medications that affect heart rate (HR) or blood pressure (BP).
  • Pregnant.
  • Currently breast-feeding women.
  • History of sleep apnea.
  • Those for emergency procedures.

研究组 & 干预措施

Group D20

Experimental

Patients will receive 0.5µg/kg dexmedetomidine (over 10 min) 20 min before induction of anesthesia then saline (over 10 min) 10 min before induction of anesthesia.

干预措施: Dexmedetomidine (Drug)

Group D10

Experimental

Patients will receive saline (over 10 min) 20 min before induction of anesthesia then 0.5µg/kg dexmedetomidine (over 10 min) 10 min before induction of anesthesia.

干预措施: Dexmedetomidine (Drug)

Group C

Placebo Comparator

Patients will receive saline before induction of anesthesia as a control group.

干预措施: Saline (Drug)

结局指标

主要结局

Mean arterial pressure

时间窗: Till the end of the surgery (Up to 2 hours)

Mean arterial pressure will be recorded at baseline, before induction, after induction, before intubation, after intubation, at 5 minutes, 10 minutes, 15 minutes, and then every 15 minutes until the end of surgery.

次要结局

  • Need for intraoperative fentanyl(Intraoperatively)
  • Heart rate(Till the end of the surgery (Up to 2 hours))
  • Incidence of adverse events(24 hours postoperatively)

研究者

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

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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