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临床试验/NCT06487988
NCT06487988已完成不适用

Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction

American University of Beirut Medical Center2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Heart rate

研究概览

简要总结

The goal of this clinical trial is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat, hoarseness, and upper airway trauma in adults aging between 18 to 55 years, scheduled for elective surgery under general anesthesia.

The main question it aims to answer is:

Does fiberoptic intubation cause less hemodynamic instability than direct oral intubation using opioid free anesthesia induction?

详细描述

Background: Intubation has always been linked to a transient increase in blood pressure and heart rate that could be deleterious in elderly and hemodynamically unstable patients. Fiberoptic intubation, which is currently used for suspected difficult intubation, could cause less marked rise in blood pressure and heart rate. Furthermore, "opioid free anesthesia" has gained popularity lately to avoid opioid adverse effects ranging from respiratory depression, postoperative ileus, sedation, nausea, vomiting and urinary retention.

Specific aims: The primary objective of this study is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat, hoarseness, and upper airway trauma.

Methods: In this prospective randomized clinical trial, 90 (45 in each group) adults aging between 18 to 55 years, scheduled for elective surgery under general anesthesia, will be recruited over 1 year of work. Patients will be randomly allocated to 2 groups: The direct conventional laryngoscopy group performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade, and the fiberoptic guided intubation group.

Significance: Studies comparing hemodynamic stability using fiberoptic intubation versus direct oral intubation in opioid free anesthesia are limited. The present study will assess whether fiberoptic intubation causes less hemodynamic instability than direct oral intubation in opioid free anesthesia induction, which will benefit patients with normal airways.

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, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •ASA (American Society of Anesthesiologists) physical status I and II
  • •Range age of 18-55 years' old
  • •Scheduled for elective surgery under general anesthesia.

排除标准

  • •History of cardiovascular diseases.
  • •History of lung disease.
  • •Hypertensive patient (BP> 140/90)
  • •Patient taking medications that affect blood pressure and heart rate
  • •Morbid obesity (BMI >30)
  • •Severe GERD
  • •Predicted difficult airway (Short TMD <6 cm, Upper li bite test grade III, Mallampati score
  • •Neck instability
  • •Patient planned to receive rapid sequence intubation
  • •Patient refusal to participate
  • •History of difficult intubation/ ventilation

研究组 & 干预措施

The direct conventional laryngoscopy group

Active Comparator

The direct conventional laryngoscopy group will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.

干预措施: direct conventional laryngoscopy (Device)

The fiberoptic guided intubation group

Experimental

The fiberoptic guided intubation will be performed.

干预措施: fiberoptic guided intubation (Device)

结局指标

主要结局

Heart rate

时间窗: baseline and up to 5 mins upon intubation

Heart rate (bpm)

Blood pressure

时间窗: baseline and up to 5 mins upon intubation

Blood pressure (mm Hg)

次要结局

  • incidence of postoperative sore throat(after 24 hrs)
  • incidence of upper airway trauma(during intubation)
  • time needed for intubation(between face mask removal and first ETCO2 reading in minutes)

研究者

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

Christian Rouphael

Clinical Instructor of Anesthesia

American University of Beirut Medical Center

研究点 (2)

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