Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine

December 6, 2024 updated by: Lauren Nakazawa, The University of Texas Health Science Center, Houston

Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine : A Prospective Non-inferiority Randomized and Blind Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Modified Time Principle Induction (MTPI) with rocuronium
Drug: 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
Active Comparator: RSI with succinylcholine
Drug: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ease of laryngoscopy
Time Frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Ease of laryngoscopy is scored categorically as easy (Jaw relaxed, no resistance to blade during laryngoscopy) , fair (Jaw not fully relaxed, some resistance to blade) or difficult (Poor jaw relaxation, active resistance by patient to laryngoscopy)
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))
Position of vocal cords is scored categorically as abducted, intermediate or closed
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))
Movement of vocal cords is scored categorically as none , moving or closing
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))
none, slight or vigorous
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))
none, diaphragm or sustained (>10s)
During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation
from the start of induction drug administration to about 5 minutes after successful ventilation
Oxygen saturation (SpO2)
Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation
from the start of induction drug administration to about 5 minutes after successful ventilation
Number of participants for whom tracheal intubations were successful on the first attempt
Time Frame: 5 minutes after intubation and successful ventilation
5 minutes after intubation and successful ventilation
Number of times tracheal intubations are attempted
Time Frame: 5 minutes after intubation and successful ventilation
5 minutes after intubation and successful ventilation
Number of participants for whom tracheal intubations failed
Time Frame: After 3 failed intubation attempts (less than 7 minutes from start of intubation)
After 3 failed intubation attempts (less than 7 minutes from start of intubation)
Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
Time Frame: from start of induction to 5 minutes of successful ventilation
Data is reported categorically as follows 1(Full view of glottis),2a(Partial view of glottis), 2b(Only posterior extremity of glottis seen or only arytenoid cartilages), 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
Satisfaction of providers with intubating conditions
Time Frame: from 5 minutes of successful ventilation
Providers will answer yes or no for satisfaction
from 5 minutes of successful ventilation
Diastolic Blood Pressure
Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation
from the start of induction drug administration to about 5 minutes after successful ventilation
Systolic Blood Pressure
Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation
from the start of induction drug administration to about 5 minutes after successful ventilation
End-tidal carbon dioxide (CO2)
Time Frame: from the start of induction drug administration to about 5 minutes after successful ventilation
from the start of induction drug administration to about 5 minutes after successful ventilation
Number of participants that had injury associated with intubation
Time Frame: within 24 hours after surgery
Injury is defined as injury to dentition, lips, tongue, and pharyngeal bleeding.
within 24 hours after surgery
Number of participants with muscle paralysis awareness prior to loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time Frame: within 24 hours after surgery
within 24 hours after surgery
Number of participants who had presence of sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time Frame: within 24 hours after surgery
This is scored from 0(no pain) to 10(worst pain)
within 24 hours after surgery
Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time Frame: within 24 hours after surgery
within 24 hours after surgery
Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time Frame: within 24 hours after surgery
within 24 hours after surgery
Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time Frame: within 24 hours after surgery
This is scored from 0(not satisfied) to 10(extremely satisfied)
within 24 hours after surgery
Number of participants who had recollection of pain on induction
Time Frame: within 24 hours after surgery
within 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lauren M Nakazawa, MD,MBA, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-23-0468

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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