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

Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: MTPI; Drug: Classic Induction

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTPI group	Drug: MTPI; 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.
Active Comparator: Classic Induction group	Drug: Classic Induction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The Cormack-Lehane classification system is a method used to categorize the airway view at the time of laryngoscopy. Data is reported categorically as follows 1(Full view of glottis),2(Partial view of glottis), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)	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
Maximum Systolic Blood Pressure		from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Diastolic Blood Pressure		from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Diastolic Blood Pressure		from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Heart Rate		from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Heart Rate		from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Oxygen Saturation (SpO2)		from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Oxygen Saturation (SpO2)		from the start of induction drug administration to about 5 minutes after successful ventilation
Expired Tidal Volume		from the start of induction drug administration to about 5 minutes after successful ventilation
End-tidal Carbon Dioxide (CO2) Level		from the start of induction drug administration to about 5 minutes after successful ventilation
Number of Participants That Had Injury Associated With Intubation	Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed	within 24 hours after surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Moved		during surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed		during surgery
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	Awareness of Muscle Paralysis or Weakness before loss of consciousness was assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction through in person interviews to evaluate explicit and implicit recall. Number of Participants with Positive Explicit recall and Positive Implicit recall are reported. Explicit recall: Participants were asked, "Describe the last thing you remember before falling asleep." If the participant describes memories of paralysis or awareness of the intubation event this is classified as positive explicit recall. If none of these memories are described it is considered negative explicit recall. Implicit recall: Participants with negative explicit recall, were asked "Did you ever feel weakness or paralysis as you fell asleep?" If they answered yes, this is classified as positive implicit recall.	within one hour after surgery
Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction	Level of throats soreness is scored from 0(no pain) to 10(worst pain), a higher number indicating worse throat soreness.	within one hour after surgery
Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction		within one hour after surgery
Overall Patient Satisfaction as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction	Patient satisfaction is scored from 0(not satisfied) to 10(extremely satisfied), a higher number indicating greater satisfaction.	within one hour after surgery
Number of Participants Who Had Recollection of Pain on Induction		within one hour after surgery
Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult"		at time of surgery
Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction		within one hour after surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Lauren M Nakazawa, MD, MBA, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): January 24, 2025
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-22-0495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No