Clinical trial NCT06029049: Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 152
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 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.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30kg/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.
* 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

Primary outcomes:
measure: Ease of laryngoscopy
timeFrame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
measure: Position of vocal cords
timeFrame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
measure: Movement of vocal cords
timeFrame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
measure: Number of participants who moved their limbs during intubation
timeFrame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
measure: number of participants who coughed during tracheal intubation
timeFrame: During procedure (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: 5 minutes after intubation and successful ventilation
measure: Number of times tracheal intubations are attempted
timeFrame: 5 minutes after intubation and 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: Satisfaction of providers with intubating conditions
timeFrame: from 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)
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: 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
timeFrame: within 24 hours 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 24 hours after surgery
measure: Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
timeFrame: within 24 hours after surgery
measure: Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
timeFrame: within 24 hours 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 24 hours after surgery
measure: Number of participants who had recollection of pain on induction
timeFrame: within 24 hours after 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: