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临床试验/NCT05509192
NCT05509192已完成4 期

Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2022年8月17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
154
试验地点
1
主要终点
The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation

研究概览

简要总结

The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • BMI >30 kg/M2 or Mallampati class III or IV
  • Requiring general anesthesia and endotracheal intubation

排除标准

  • Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
  • American Society of Anesthesiologists (ASA) physical status classification > III
  • Emergency surgery
  • Induction requiring cricoid pressure
  • Patients requiring awake intubation
  • Pregnant women
  • Patients who require an induction dose of propofol less than 1 mg/kg
  • Untreated ischemic heart disease
  • Contraindication to mask ventilation
  • Allergy to propofol, rocuronium, or Sugammadex
  • Induction requiring succinylcholine

研究组 & 干预措施

MTPI group

Experimental

干预措施: MTPI (Drug)

Classic Induction group

Active Comparator

干预措施: Classic Induction (Drug)

结局指标

主要结局

The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation

时间窗: Between laryngoscope insertion to onset of ventilation (less than 7 minutes)

次要结局

  • Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt(after 5 minutes of successful ventilation)
  • Number of Times Tracheal Intubations Are Attempted(after 5 minutes of successful ventilation)
  • Number of Participants for Whom Tracheal Intubations Failed(after 3 failed intubation attempts (less than 7 minutes from start of intubation))
  • Airway Cord View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)(from start of induction to 5 minutes of successful ventilation)
  • Minimum Systolic Blood Pressure(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Maximum Systolic Blood Pressure(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Minimum Diastolic Blood Pressure(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Maximum Diastolic Blood Pressure(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Minimum Heart Rate(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Maximum Heart Rate(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Minimum Oxygen Saturation (SpO2)(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Maximum Oxygen Saturation (SpO2)(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Expired Tidal Volume(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • End-tidal Carbon Dioxide (CO2) Level(from the start of induction drug administration to about 5 minutes after successful ventilation)
  • Number of Participants That Had Injury Associated With Intubation(within 24 hours after surgery)
  • Physical Response During Intubation, as Assessed by the Number of Participants Who Moved(during surgery)
  • Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed(during surgery)
  • Number of Participants Who Had Awareness of Muscle Paralysis Before Loss of Consciousness as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within one hour after surgery)
  • Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within one hour after surgery)
  • Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within one hour after surgery)
  • Overall Patient Satisfaction as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within one hour after surgery)
  • Number of Participants Who Had Recollection of Pain on Induction(within one hour after surgery)
  • Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult"(at time of surgery)
  • Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within one hour after surgery)

研究者

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

Lauren Nakazawa

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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