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Phase 4 Completed N=154 Randomized Triple-blind Treatment

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

Anesthesia
Source: ClinicalTrials.gov NCT05509192 ↗
Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation — 30.0; 33.0 seconds
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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