Clinical trial NCT05509192: Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction
Official title: Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The total time between laryngoscope insertion into mouth and the onset of ventilation after tracheal intubation
timeFrame: Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
Secondary outcomes:
measure: Number of participants for whom tracheal intubations were successful on the first attempt
timeFrame: after 5 minutes of successful ventilation
measure: Number of times tracheal intubations are attempted
timeFrame: after 5 minutes of successful ventilation
measure: Number of participants for whom tracheal intubations failed
timeFrame: after 3 failed intubation attempts (less than 7 minutes from start of intubation)
measure: Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
timeFrame: from start of induction to 5 minutes of successful ventilation
measure: Heart Rate
timeFrame: from the start of induction drug administration to about 5 minutes after successful ventilation
measure: Diastolic blood pressure
timeFrame: from the start of induction drug administration to about 5 minutes after successful ventilation
measure: Systolic blood pressure
timeFrame: from the start of induction drug administration to about 5 minutes after successful ventilation
measure: End-tidal carbon dioxide (CO2) level
timeFrame: from the start of induction drug administration to about 5 minutes after successful ventilation
measure: Oxygen saturation (SpO2)
timeFrame: from the start of induction drug administration to about 5 minutes after successful ventilation
measure: Number of participants that had injury associated with intubation
timeFrame: within 24 hours after surgery
measure: Physical response during intubation, as assessed by the number of participants who moved
timeFrame: during surgery
measure: Physical response during intubation, as assessed by the number of participants who coughed
timeFrame: during surgery
measure: 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
timeFrame: within one hour after surgery
measure: 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
timeFrame: within one hour after surgery
measure: Number of participants who had nausea and vomiting as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
timeFrame: within one hour after surgery
measure: Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
timeFrame: within one hour after surgery
measure: Number of participants who had recollection of pain on induction
timeFrame: within one hour after surgery
measure: Provider determination of intubating conditions, based on whether intubation was classified as "Not difficult" or "Difficult"
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lauren M Nakazawa, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: