Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction
Phase 4
Completed
- Conditions
- Anesthesia
- Interventions
- Drug: MTPIDrug: Classic Induction
- Registration Number
- NCT05509192
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
Inclusion Criteria
- BMI >30 kg/M2 or Mallampati class III or IV
- Requiring general anesthesia and endotracheal intubation
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MTPI group MTPI - Classic Induction group Classic Induction -
- Primary Outcome Measures
Name Time Method The total time between laryngoscope insertion into mouth and the onset of ventilation after tracheal intubation Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
- Secondary Outcome Measures
Name Time Method 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 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 data is reported categorically as follows 1(Full view of glottis),2a(Partial view of glottis), 2b(Only posterior extremity of glottis seen or only arytenoid cartilages), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)
Heart Rate from the start of induction drug administration to about 5 minutes after 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) level from the start of induction drug administration to about 5 minutes after successful ventilation Oxygen saturation (SpO2) 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 Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed
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 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 one hour after surgery This is scored from 0(no pain) to 10(worst pain)
Number of participants who had nausea and vomiting 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 the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction within one hour after surgery This is scored from 0(not satisfied) to 10(extremely satisfied)
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
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States