Phase 4
N=154
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT05509192 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation — 30.0; 33.0 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MTPI (Drug); Classic Induction (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation |
30.0; 33.0 | — |
| SECONDARY Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt |
62; 66 | — |
| SECONDARY Number of Times Tracheal Intubations Are Attempted |
62; 66; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants for Whom Tracheal Intubations Failed |
0; 0 | — |
| SECONDARY Airway Cord View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation) |
32; 30; 32; 34; 0; 4 | — |
| SECONDARY Minimum Systolic Blood Pressure |
130.6; 117.4 | — |
| SECONDARY Maximum Systolic Blood Pressure |
150.7; 145.3 | — |
| SECONDARY Minimum Diastolic Blood Pressure |
77.2; 69.4 | — |
| SECONDARY Maximum Diastolic Blood Pressure |
94.5; 92.0 | — |
| SECONDARY Minimum Heart Rate |
77.3; 69.0 | — |
| SECONDARY Maximum Heart Rate |
103.6; 103.0 | — |
| SECONDARY Minimum Oxygen Saturation (SpO2) |
95.3; 96.5 | — |
| SECONDARY Maximum Oxygen Saturation (SpO2) |
99.7; 99.8 | — |
| SECONDARY Expired Tidal Volume |
503.8; 507.3 | — |
| SECONDARY End-tidal Carbon Dioxide (CO2) Level |
32.2; 32.9 | — |
| SECONDARY Number of Participants That Had Injury Associated With Intubation |
0; 0 | — |
| SECONDARY Physical Response During Intubation, as Assessed by the Number of Participants Who Moved |
0; 2 | — |
| SECONDARY Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed |
0; 0 | — |
| SECONDARY Number of Participants Who Had Awareness of Muscle Paralysis Before Loss of Consciousness as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |
0; 0; 2; 3 | — |
| SECONDARY Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |
3.3; 3.1 | — |
| SECONDARY Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |
11; 9 | — |
| SECONDARY Overall Patient Satisfaction as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |
9.3; 9.4 | — |
| SECONDARY Number of Participants Who Had Recollection of Pain on Induction |
4; 0 | — |
| SECONDARY Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult" |
1; 3; 63; 65 | — |
| SECONDARY Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |
0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- BMI >30 kg/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
- 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
Data sourced from ClinicalTrials.gov (NCT05509192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.