Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine : A Prospective Non-inferiority Randomized and Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Ease of laryngoscopy
研究概览
简要总结
The purpose of this study is to assess and compare conditions for tracheal intubation obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy, vocal cord view, vocal cord opening, and movement of limbs and coughing during tracheal intubation in order to assess intubation conditions, to compare efficiency and success rate of tracheal intubation between two induction agents and to determine the rate of patient awareness during induction and post-operative recall of paralysis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 30kg/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.
- •The American Society of Anesthesiologists (ASA) physical status classification > III.
- •Patients requiring awake intubation.
- •Pregnant women.
- •Untreated ischemic heart disease.
- •Patients requiring an induction dose of propofol < 1 mg/kg.
- •Allergy to propofol, rocuronium, succinylcholine, or sugammadex.
- •Patients with renal failure and unknown potassium (K+) level, or patients with K+ level > 5.0
- •Personal history of malignant hyperthermia (MH), or family history of MH
- •Patients with suspected or diagnosed neuromuscular disease, patients with burn injuries
研究组 & 干预措施
Modified Time Principle Induction (MTPI) with rocuronium
干预措施: Modified Time Principle Induction (MTPI) with rocuronium (Drug)
RSI with succinylcholine
干预措施: RSI succinylcholine (Drug)
结局指标
主要结局
Ease of laryngoscopy
时间窗: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Ease of laryngoscopy is scored categorically as easy (Jaw relaxed, no resistance to blade during laryngoscopy) , fair (Jaw not fully relaxed, some resistance to blade) or difficult (Poor jaw relaxation, active resistance by patient to laryngoscopy)
Position of vocal cords
时间窗: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Position of vocal cords is scored categorically as abducted, intermediate or closed
Movement of vocal cords
时间窗: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Movement of vocal cords is scored categorically as none , moving or closing
Number of participants who moved their limbs during intubation
时间窗: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
none, slight or vigorous
number of participants who coughed during tracheal intubation
时间窗: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
none, diaphragm or sustained (\>10s)
次要结局
- Airway 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)
- Diastolic Blood Pressure(from the start of induction drug administration to about 5 minutes after successful ventilation)
- Systolic Blood Pressure(from the start of induction drug administration to about 5 minutes after successful ventilation)
- End-tidal carbon dioxide (CO2)(from the start of induction drug administration to about 5 minutes after successful ventilation)
- Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within 24 hours after surgery)
- Number of times tracheal intubations are attempted(5 minutes after intubation and successful ventilation)
- Number of participants for whom tracheal intubations failed(After 3 failed intubation attempts (less than 7 minutes from start of intubation))
- Number of participants for whom tracheal intubations were successful on the first attempt(5 minutes after intubation and successful ventilation)
- Satisfaction of providers with intubating conditions(from 5 minutes of successful ventilation)
- Oxygen saturation (SpO2)(from the start of induction drug administration to about 5 minutes after successful ventilation)
- Heart Rate(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)
- Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within 24 hours after surgery)
- Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within 24 hours after surgery)
- Number of participants with muscle paralysis awareness prior to loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within 24 hours after surgery)
- Number of participants who had presence of sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction(within 24 hours after surgery)
- Number of participants who had recollection of pain on induction(within 24 hours after surgery)
研究者
Lauren Nakazawa
Assistant Professor
The University of Texas Health Science Center, Houston