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

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

Tracking Information

• First Submitted Date: August 22, 2023
• First Posted Date: September 8, 2023
• Last Update Posted Date: December 1, 2023
• Actual Study Start Date: September 13, 2023
• Estimated Primary Completion Date: September 12, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2023)

• 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)
• 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
• 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
• 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
• 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2023)

• Number of participants for whom tracheal intubations were successful on the first attempt [ Time Frame: 5 minutes after intubation and successful ventilation ]
• Number of times tracheal intubations are attempted [ Time Frame: 5 minutes after intubation and successful ventilation ]
• Number of participants for whom tracheal intubations failed [ Time Frame: After 3 failed intubation attempts (less than 7 minutes from start of intubation) ]
• 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)
• Satisfaction of providers with intubating conditions [ Time Frame: from 5 minutes of successful ventilation ]
  Providers will answer yes or no for satisfaction
• Heart Rate [ Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation ]
• Diastolic Blood Pressure [ Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation ]
• Systolic Blood Pressure [ Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation ]
• End-tidal carbon dioxide (CO2) [ Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation ]
• Oxygen saturation (SpO2) [ Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation ]
• 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.
• 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 ]
• 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)
• 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 ]
• 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 ]
• 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)
• Number of participants who had recollection of pain on induction [ Time Frame: within 24 hours after surgery ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Anesthesia

Intervention

• 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
• 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

Study Arms

• Experimental: Modified Time Principle Induction (MTPI) with rocuronium
  Intervention: Drug: Modified Time Principle Induction (MTPI) with rocuronium
• Active Comparator: RSI with succinylcholine
  Intervention: Drug: RSI succinylcholine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 31, 2023): 152
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 12, 2024
• Estimated Primary Completion Date: September 12, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06029049
• Other Study ID Numbers: HSC-MS-23-0468
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lauren Nakazawa, The University of Texas Health Science Center, Houston
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lauren M Nakazawa, MD,MBA; The University of Texas Health Science Center, Houston

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: November 2023