Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction

NCT05509192 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-22-0495
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation

  Between laryngoscope insertion to onset of ventilation (less than 7 minutes)

Secondary Outcomes (24)

• Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt

  after 5 minutes of successful ventilation

• Number of Times Tracheal Intubations Are Attempted

  after 5 minutes of successful ventilation

• Number of Participants for Whom Tracheal Intubations Failed

  after 3 failed intubation attempts (less than 7 minutes from start of intubation)

• Airway Cord 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

• Minimum Systolic Blood Pressure

  from the start of induction drug administration to about 5 minutes after successful ventilation

Study Arms (2)

MTPI group

EXPERIMENTAL

Drug: MTPI

Classic Induction group

ACTIVE COMPARATOR

Drug: Classic Induction

Interventions

MTPI DRUG

Patients from both study groups will receive premedication in the usual fashion, typically 0-2 mg of IV midazolam at the discretion of the care team. Patients in both study groups will receive 1 mg/kg of lidocaine intravenously, followed by an opioid such as fentanyl (1-2 mcg/kg), prior to administration of induction drugs. Patients assigned to MTPI will then be given rocuronium (0.6mg/kg), followed by propofol intravenously as a single bolus within 10 seconds. A typical propofol bolus for induction ranges from 1-2mg/kg, depending on the patient's age, medical history, and co-morbidities. Propofol dosing will be at the discretion of the care team. Patients will count down from one hundred. Once apnea occurs, as indicated by a lack of respiratory effort, the eyes will be taped, and intubation with C-MAC (Karl Storz 8403ZX, Tuttlingen, Germany) is initiated.

MTPI group

Classic Induction DRUG

Patients assigned to CI will be induced as per routine care using lidocaine 1 mg/kg, an opioid such a fentanyl (1-2 mcg/kg), propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg, and the intubation will be performed with a C-MAC. Patients will also count down from one hundred. The medications used for induction of anesthesia in both arms of the study are those used for routine anesthesia care. In both study arms, dosing of medications for induction of anesthesia is standardized (lidocaine 1 mg/kg, fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg). The only difference between the two arms will be the timing of the medication administration, and the order in which medications are administered. The documentation of induction and intubation will be the same as that of the MTPI group. Vital signs and other parameters will continuously be recorded in the intraoperative record. Emergence and extubation are not protocolized.

Classic Induction group

Eligibility Criteria

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

You may qualify if:

• BMI \>30 kg/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
• American Society of Anesthesiologists (ASA) physical status classification \> III
• Emergency surgery
• Induction requiring cricoid pressure
• Patients requiring awake intubation
• Pregnant women
• Patients who require an induction dose of propofol less than 1 mg/kg
• Untreated ischemic heart disease
• Contraindication to mask ventilation
• Allergy to propofol, rocuronium, or Sugammadex
• Induction requiring succinylcholine

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

Location

Results Point of Contact

• Title: Lauren M Nakazawa, MD, MBA
• Organization: The University of Texas Health Science Center at Houston

Lauren.M.Nakazawa@uth.tmc.edu

713-500-6775

Study Officials

• Lauren M Nakazawa, MD, MBA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: August 17, 2022
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)