Recruiting

Rocuronium vs. Succinylcholine

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06029049

Conditions

Anesthesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Modified Time Principle Induction (MTPI) with rocuronium

RSI succinylcholine

Study Details

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

Study ID

NCT06029049

Start date

Sep 13, 2023

Status verified date

Dec, 2024

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Modified Time Principle Induction (MTPI) with rocuronium

active comparator: RSI with succinylcholine

Interventions

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

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

Primary outcome measure

  • Ease of laryngoscopy [ Time Frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) ]
  • Position of vocal cords [ Time Frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) ]
  • Movement of vocal cords [ Time Frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) ]
  • Number of participants who moved their limbs during intubation [ Time Frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) ]
  • number of participants who coughed during tracheal intubation [ Time Frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) ]

Central Contacts and Locations

Central contacts

Lauren M Nakazawa, MD,MBA

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

Ellie Tuchaai

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Lauren M Nakazawa, MD,MBA

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

Ellie Tuchaai

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 10, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-12-10.