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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Modified Time Principle Induction (MTPI) with rocuronium; Drug: RSI succinylcholine

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lauren M Nakazawa, MD,MBA; Phone Number: 713-500-6775; Email: Lauren.M.Nakazawa@uth.tmc.edu
• Study Contact Backup: Name: Ellie Tuchaai; Phone Number: 713.614.9355; Email: Ellie.J.Tuchaai@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Lauren M Nakazawa, MD,MBA; Phone Number: 713-500-6775; Email: Lauren.M.Nakazawa@uth.tmc.edu
      • Contact: Ellie Tuchaai; Phone Number: 713.614.9355; Email: Ellie.J.Tuchaai@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of laryngoscopy	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)	During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Position of vocal cords	Position of vocal cords is scored categorically as abducted, intermediate or closed	During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Movement of vocal cords	Movement of vocal cords is scored categorically as none , moving or closing	During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Number of participants who moved their limbs during intubation	none, slight or vigorous	During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
number of participants who coughed during tracheal intubation	none, diaphragm or sustained (>10s)	During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate		from the start of induction drug administration to about 5 minutes after successful ventilation
Oxygen saturation (SpO2)		from the start of induction drug administration to about 5 minutes after successful ventilation
Number of participants for whom tracheal intubations were successful on the first attempt		5 minutes after intubation and successful ventilation
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)
Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)	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)	from start of induction to 5 minutes of successful ventilation
Satisfaction of providers with intubating conditions	Providers will answer yes or no for satisfaction	from 5 minutes of successful ventilation
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 that had injury associated with intubation	Injury is defined as injury to dentition, lips, tongue, and pharyngeal bleeding.	within 24 hours after surgery
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	This is scored from 0(no pain) to 10(worst pain)	within 24 hours after surgery
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 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	This is scored from 0(not satisfied) to 10(extremely satisfied)	within 24 hours after surgery
Number of participants who had recollection of pain on induction		within 24 hours after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): September 12, 2024
• Study Completion (Estimated): September 12, 2024

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Rocuronium; Succinylcholine
• Other Study ID Numbers: HSC-MS-23-0468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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