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NCT Number: NCT06029049

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Time Principle Induction (MTPI) with rocuronium

Drug

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

RSI succinylcholine

Drug

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

Primary outcomes

  1. Ease of laryngoscopy

    Time frame: 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)

  2. Position of vocal cords

    Time frame: 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

  3. Movement of vocal cords

    Time frame: 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

  4. Number of participants who moved their limbs during intubation

    Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))

    none, slight or vigorous

  5. number of participants who coughed during tracheal intubation

    Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))

    none, diaphragm or sustained (>10s)

Secondary outcomes

  1. Number of participants for whom tracheal intubations were successful on the first attempt

    Time frame: 5 minutes after intubation and successful ventilation

  2. Number of times tracheal intubations are attempted

    Time frame: 5 minutes after intubation and successful ventilation

  3. Number of participants for whom tracheal intubations failed

    Time frame: After 3 failed intubation attempts (less than 7 minutes from start of intubation)

  4. Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)

    Time frame: 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)

  5. Satisfaction of providers with intubating conditions

    Time frame: from 5 minutes of successful ventilation

    Providers will answer yes or no for satisfaction

  6. Heart Rate

    Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

  7. Diastolic Blood Pressure

    Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

  8. Systolic Blood Pressure

    Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

  9. End-tidal carbon dioxide (CO2)

    Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

  10. Oxygen saturation (SpO2)

    Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

  11. Number of participants that had injury associated with intubation

    Time frame: within 24 hours after surgery

    Injury is defined as injury to dentition, lips, tongue, and pharyngeal bleeding.

  12. 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

    Time frame: within 24 hours after surgery

  13. 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

    Time frame: within 24 hours after surgery

    This is scored from 0(no pain) to 10(worst pain)

  14. Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

    Time frame: within 24 hours after surgery

  15. Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

    Time frame: within 24 hours after surgery

  16. Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

    Time frame: within 24 hours after surgery

    This is scored from 0(not satisfied) to 10(extremely satisfied)

  17. Number of participants who had recollection of pain on induction

    Time frame: within 24 hours after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Ellie Tuchaai

CONTACT

[email protected]

713.614.9355

Lauren M Nakazawa, MD,MBA

CONTACT

[email protected]

713-500-6775

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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