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临床试验/NCT06592027
NCT06592027已完成4 期

Optimal Dose of Dexmedetomidine for Attenuation of Endotracheal Intubation Pressor Response Using Cardiometry. a Randomized, Double-blinded Study

Theodor Bilharz Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Heart rate measurment

研究概览

简要总结

Direct laryngoscopy and tracheal intubation are usually associated by hemodynamic changes due to increased sympathoadrenal activity which could precipitate serious negative effects in compromised patients . The pressor response could be blunted by dexmedetomidine which is a selective alpha 2 agonist which might provide hemodynamic stability during tracheal intubation.

详细描述

Various drugs include local anesthetics, beta-blockers, calcium channel blockers, and narcotic analgesics have been tried to blunt the laryngoscopy and intubation response, with varied success. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. Its various effects have led to its increasing use for reducing anesthetic and analgesic requirements in the perioperative period. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation. Electrical cardiometry is recently introduced for assessment of many cardiovascular variables and continuously applicable method of cardiac output (CO), stroke volume (SV), and other hemodynamic parameters monitoring. Its use is growing because it is non-invasive, shows reliability in CO measurements and can be used as a continuous bedside monitor Although different doses of dexmedetomidine (0.5- 2.0 μg/kg) have been used in various studies which suggested its efficacy in blunting the hemodynamic pressor response , However, no studies to the best of our knowledge had incorporated CO monitoring for detection of minimal hemodynamic changes during laryngoscopy and endotracheal intubation which can be best achieved by using Cardiometry monitor.

In this study, we will compare two doses of dexmedetomidine for prophylaxis against pressor response of ETI using cardiometry.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1 - ASA physical status 1-
  • Age 18- 60 years old of both sexes.
  • Patients undergoing elective surgery under general anesthesia and tracheal intubation.

排除标准

  • Age < 18 years and ≥ 60 years
  • Emergency surgery or full stomach
  • Renal or Hepatic patients
  • Patients with suspected difficult airway {e.g., high neck circumference, high body mass index (above 30 kg/m2), airway masses, mouth scars, neck scars, limited neck extension or history of snoring.
  • Total duration of laryngoscopy will be noted and in cases where duration exceeded 15 sec the case will be excluded from the study.
  • Any patient on regular intake of beta blockers or calcium channel blockers
  • Patients with any known hypersensitivity or contraindication to dexmedetomidine,
  • Patients with significant neurological, psychiatric, or neuromuscular disorders.

研究组 & 干预措施

Group A

Placebo Comparator

this group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion

干预措施: PRECEDEX INJ★ 2ML (Drug)

Group B

Active Comparator

this group will receive single dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion

干预措施: PRECEDEX INJ★ 2ML (Drug)

结局指标

主要结局

Heart rate measurment

时间窗: after 1 minute of successful tracheal intubation

single measurement after intubation

次要结局

  • cardiac output(from the start of induction of anesthesia till 5 minutes after successful tracheal intubation)

研究者

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

Moshira sayed mohamed

Lecturer of anesthesia and intensive care

Theodor Bilharz Research Institute

研究点 (1)

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