Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Modified Time Principle Induction (MTPI) with rocuronium
  Participants will be induced using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, followed by 0.6 mg/kg IV rocuronium, and IV propofol with dosage at the discretion of the care team, administered within 10 seconds of rocuronium and the intubation will be performed with a C-MAC
• Препарат RSI succinylcholine
  Participants will be induced as per routine care using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, propofol 1-2 mg/kg IV, and succinylcholine 1mg/kg IV, and the intubation will be performed with a C-MAC

Первичные конечные точки

• Ease of laryngoscopy [Срок оценки: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))]
• Position of vocal cords [Срок оценки: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))]
• Movement of vocal cords [Срок оценки: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))]
• Number of participants who moved their limbs during intubation [Срок оценки: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))]
• number of participants who coughed during tracheal intubation [Срок оценки: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))]

Вторичные конечные точки (12)

• Number of participants for whom tracheal intubations were successful on the first attempt [Срок оценки: 5 minutes after intubation and successful ventilation]
• Number of times tracheal intubations are attempted [Срок оценки: 5 minutes after intubation and successful ventilation]
• Number of participants for whom tracheal intubations failed [Срок оценки: After 3 failed intubation attempts (less than 7 minutes from start of intubation)]
• Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation) [Срок оценки: from start of induction to 5 minutes of successful ventilation]
• Satisfaction of providers with intubating conditions [Срок оценки: from 5 minutes of successful ventilation]
• Heart Rate [Срок оценки: from the start of induction drug administration to about 5 minutes after successful ventilation]
• Diastolic Blood Pressure [Срок оценки: from the start of induction drug administration to about 5 minutes after successful ventilation]
• Systolic Blood Pressure [Срок оценки: from the start of induction drug administration to about 5 minutes after successful ventilation]
• End-tidal carbon dioxide (CO2) [Срок оценки: from the start of induction drug administration to about 5 minutes after successful ventilation]
• Oxygen saturation (SpO2) [Срок оценки: from the start of induction drug administration to about 5 minutes after successful ventilation]
• Number of participants that had injury associated with intubation [Срок оценки: 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 [Срок оценки: within 24 hours after surgery]

Критерии участия

Критерии включения

• BMI > 30kg/m2 or Mallampati class III or IV.
• Requiring general anesthesia and endotracheal intubation

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06029049 · HSC-MS-23-0468

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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