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

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ClinicalTrials.gov Identifier: NCT06029049
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : December 1, 2023
Sponsor:
Information provided by (Responsible Party):
Lauren Nakazawa, The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Modified Time Principle Induction (MTPI) with rocuronium Drug: RSI succinylcholine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 13, 2023
Estimated Primary Completion Date : September 12, 2024
Estimated Study Completion Date : September 12, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Time Principle Induction (MTPI) with rocuronium Drug: Modified Time Principle Induction (MTPI) with rocuronium
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
Active Comparator: RSI with succinylcholine Drug: RSI succinylcholine
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029049


Contacts
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Contact: Lauren M Nakazawa, MD,MBA 713-500-6775 Lauren.M.Nakazawa@uth.tmc.edu
Contact: Ellie Tuchaai 713.614.9355 Ellie.J.Tuchaai@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Lauren M Nakazawa, MD,MBA    713-500-6775    Lauren.M.Nakazawa@uth.tmc.edu   
Contact: Ellie Tuchaai    713.614.9355    Ellie.J.Tuchaai@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Lauren M Nakazawa, MD,MBA The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Lauren Nakazawa, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT06029049    
Other Study ID Numbers: HSC-MS-23-0468
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rocuronium
Succinylcholine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents