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

NCT06029049 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HSC-MS-23-0468
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (17)

• 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)

  from start of induction to 5 minutes of successful ventilation

• Satisfaction of providers with intubating conditions

  from 5 minutes of successful ventilation

Study Arms (2)

Modified Time Principle Induction (MTPI) with rocuronium

EXPERIMENTAL

Drug: Modified Time Principle Induction (MTPI) with rocuronium

RSI with succinylcholine

ACTIVE COMPARATOR

Drug: RSI succinylcholine

Interventions

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

Modified Time Principle Induction (MTPI) with rocuronium

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

RSI with succinylcholine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 30kg/m2 or Mallampati class III or IV.
• Requiring general anesthesia and endotracheal intubation

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Lauren M Nakazawa, MD,MBA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren M Nakazawa, MD,MBA

CONTACT

713-500-6775; Lauren.M.Nakazawa@uth.tmc.edu

Ellie Tuchaai

CONTACT

713.614.9355; Ellie.J.Tuchaai@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 8, 2023
• Study Start: September 13, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)