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Completed

NCT Number: NCT05509192

Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MTPI

Drug

Patients from both study groups will receive premedication in the usual fashion, typically 0-2 mg of IV midazolam at the discretion of the care team. Patients in both study groups will receive 1 mg/kg of lidocaine intravenously, followed by an opioid such as fentanyl (1-2 mcg/kg), prior to administration of induction drugs. Patients assigned to MTPI will then be given rocuronium (0.6mg/kg), followed by propofol intravenously as a single bolus within 10 seconds. A typical propofol bolus for induction ranges from 1-2mg/kg, depending on the patient's age, medical history, and co-morbidities. Propofol dosing will be at the discretion of the care team. Patients will count down from one hundred. Once apnea occurs, as indicated by a lack of respiratory effort, the eyes will be taped, and intubation with C-MAC (Karl Storz 8403ZX, Tuttlingen, Germany) is initiated.

Classic Induction

Drug

Patients assigned to CI will be induced as per routine care using lidocaine 1 mg/kg, an opioid such a fentanyl (1-2 mcg/kg), propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg, and the intubation will be performed with a C-MAC. Patients will also count down from one hundred. The medications used for induction of anesthesia in both arms of the study are those used for routine anesthesia care. In both study arms, dosing of medications for induction of anesthesia is standardized (lidocaine 1 mg/kg, fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg). The only difference between the two arms will be the timing of the medication administration, and the order in which medications are administered. The documentation of induction and intubation will be the same as that of the MTPI group. Vital signs and other parameters will continuously be recorded in the intraoperative record. Emergence and extubation are not protocolized.

Primary outcomes

  1. The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation

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

Secondary outcomes

  1. Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt

    Time frame: after 5 minutes of successful ventilation

  2. Number of Times Tracheal Intubations Are Attempted

    Time frame: after 5 minutes of 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 Cord 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

    The Cormack-Lehane classification system is a method used to categorize the airway view at the time of laryngoscopy. Data is reported categorically as follows 1(Full view of glottis),2(Partial view of glottis), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)

  5. Minimum Systolic Blood Pressure

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

  6. Maximum Systolic Blood Pressure

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

  7. Minimum Diastolic Blood Pressure

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

  8. Maximum Diastolic Blood Pressure

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

  9. Minimum Heart Rate

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

  10. Maximum Heart Rate

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

  11. Minimum Oxygen Saturation (SpO2)

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

  12. Maximum Oxygen Saturation (SpO2)

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

  13. Expired Tidal Volume

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

  14. End-tidal Carbon Dioxide (CO2) Level

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

  15. Number of Participants That Had Injury Associated With Intubation

    Time frame: within 24 hours after surgery

    Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed

  16. Physical Response During Intubation, as Assessed by the Number of Participants Who Moved

    Time frame: during surgery

  17. Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed

    Time frame: during surgery

  18. 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

    Time frame: within one hour after surgery

    Awareness of Muscle Paralysis or Weakness before loss of consciousness was assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction through in person interviews to evaluate explicit and implicit recall. Number of Participants with Positive Explicit recall and Positive Implicit recall are reported.

    Explicit recall: Participants were asked, "Describe the last thing you remember before falling asleep." If the participant describes memories of paralysis or awareness of the intubation event this is classified as positive explicit recall. If none of these memories are described it is considered negative explicit recall.

    Implicit recall: Participants with negative explicit recall, were asked "Did you ever feel weakness or paralysis as you fell asleep?" If they answered yes, this is classified as positive implicit recall.

  19. Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

    Time frame: within one hour after surgery

    Level of throats soreness is scored from 0(no pain) to 10(worst pain), a higher number indicating worse throat soreness.

  20. Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

    Time frame: within one hour after surgery

  21. Overall Patient Satisfaction as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

    Time frame: within one hour after surgery

    Patient satisfaction is scored from 0(not satisfied) to 10(extremely satisfied), a higher number indicating greater satisfaction.

  22. Number of Participants Who Had Recollection of Pain on Induction

    Time frame: within one hour after surgery

  23. Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult"

    Time frame: at time of surgery

  24. Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

    Time frame: within one hour after surgery

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2022
Registry last updated
Feb 11, 2026

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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