Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine
- Conditions
- Anesthesia
- Interventions
- Drug: Modified Time Principle Induction (MTPI) with rocuronium
- Registration Number
- NCT06029049
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 152
- BMI > 30kg/m2 or Mallampati class III or IV.
- Requiring general anesthesia and endotracheal intubation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RSI with succinylcholine RSI succinylcholine - Modified Time Principle Induction (MTPI) with rocuronium Modified Time Principle Induction (MTPI) with rocuronium -
- Primary Outcome Measures
Name Time Method Ease of laryngoscopy 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 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 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 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 During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) none, diaphragm or sustained (\>10s)
- Secondary Outcome Measures
Name Time Method 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)
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 Providers will answer yes or no for satisfaction
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 Injury is defined as injury to dentition, lips, tongue, and pharyngeal bleeding.
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 This is scored from 0(not satisfied) to 10(extremely satisfied)
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 This is scored from 0(no pain) to 10(worst pain)
Number of participants who had recollection of pain on induction within 24 hours after surgery
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States