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

Primary Purpose

Anesthesia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MTPI
Classic Induction
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MTPI group

Classic Induction group

Arm Description

Outcomes

Primary Outcome Measures

The total time between laryngoscope insertion into mouth and the onset of ventilation after tracheal intubation

Secondary Outcome Measures

Number of participants for whom tracheal intubations were successful on the first attempt
Number of times tracheal intubations are attempted
Number of participants for whom tracheal intubations failed
Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
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)
Heart Rate
Diastolic blood pressure
Systolic blood pressure
End-tidal carbon dioxide (CO2) level
Oxygen saturation (SpO2)
Number of participants that had injury associated with intubation
Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed
Physical response during intubation, as assessed by the number of participants who moved
Physical response during intubation, as assessed by the number of participants who coughed
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
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
This is scored from 0(no pain) to 10(worst pain)
Number of participants who had nausea and vomiting as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
This is scored from 0(not satisfied) to 10(extremely satisfied)
Number of participants who had recollection of pain on induction

Full Information

First Posted
August 16, 2022
Last Updated
May 8, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05509192
Brief Title
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction
Official Title
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MTPI group
Arm Type
Experimental
Arm Title
Classic Induction group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MTPI
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Classic Induction
Intervention Description
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.
Primary Outcome Measure Information:
Title
The total time between laryngoscope insertion into mouth and the onset of ventilation after tracheal intubation
Time Frame
Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
Secondary Outcome Measure Information:
Title
Number of participants for whom tracheal intubations were successful on the first attempt
Time Frame
after 5 minutes of successful ventilation
Title
Number of times tracheal intubations are attempted
Time Frame
after 5 minutes of successful ventilation
Title
Number of participants for whom tracheal intubations failed
Time Frame
after 3 failed intubation attempts (less than 7 minutes from start of intubation)
Title
Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
Description
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)
Time Frame
from start of induction to 5 minutes of successful ventilation
Title
Heart Rate
Time Frame
from the start of induction drug administration to about 5 minutes after successful ventilation
Title
Diastolic blood pressure
Time Frame
from the start of induction drug administration to about 5 minutes after successful ventilation
Title
Systolic blood pressure
Time Frame
from the start of induction drug administration to about 5 minutes after successful ventilation
Title
End-tidal carbon dioxide (CO2) level
Time Frame
from the start of induction drug administration to about 5 minutes after successful ventilation
Title
Oxygen saturation (SpO2)
Time Frame
from the start of induction drug administration to about 5 minutes after successful ventilation
Title
Number of participants that had injury associated with intubation
Description
Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed
Time Frame
within 24 hours after surgery
Title
Physical response during intubation, as assessed by the number of participants who moved
Time Frame
during surgery
Title
Physical response during intubation, as assessed by the number of participants who coughed
Time Frame
during surgery
Title
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
Time Frame
within one hour after surgery
Title
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
Description
This is scored from 0(no pain) to 10(worst pain)
Time Frame
within one hour after surgery
Title
Number of participants who had nausea and vomiting as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time Frame
within one hour after surgery
Title
Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Description
This is scored from 0(not satisfied) to 10(extremely satisfied)
Time Frame
within one hour after surgery
Title
Number of participants who had recollection of pain on induction
Time Frame
within one hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren M Nakazawa, MD, MBA
Phone
713-500-6775
Email
Lauren.M.Nakazawa@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kyle A Chi
Phone
972-352-1424
Email
Kyle.Alyson.Chi@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren M Nakazawa, MD, MBA
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren M Nakazawa, MD, MBA
Phone
713-500-6775
Email
Lauren.M.Nakazawa@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Kyle Chi
Phone
972-352-1424
Email
Kyle.Alyson.Chi@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Yandong Jiang, MD
First Name & Middle Initial & Last Name & Degree
Travis Markham, MD
First Name & Middle Initial & Last Name & Degree
Carolyn Fan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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