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Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant

Primary Purpose

Muscle Relaxant

Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Videolaryngoscope
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Relaxant focused on measuring McGrath®, Videolaryngoscope, intubating condition, muscle relaxant, intubation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-65 years old.
  • ASA class I-II.
  • Elective surgery required general anesthesia with oroendotracheal intubation

Exclusion Criteria:

  • Suspected or known difficult airway.
  • Patient with risk of aspiration with required of rapid sequence induction .
  • Plan remained intubation.
  • Allergic to drugs used in the study.
  • Renal or hepatic disease.

Sites / Locations

  • Department of anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Muscle relaxant

Placebo

Arm Description

Intubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg muscle relaxant use rocuronium 0.6 mg/kg

Intubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg placebo use NSS 0.6 mg/kg

Outcomes

Primary Outcome Measures

Intubating condition.
number of participants with 34 people

Secondary Outcome Measures

Success rate in the first attempt intubation.
Time to intubation
The required propofol dose for intubation without muscle relaxant.
Events during the intubation attempts occurred.

Full Information

First Posted
October 7, 2015
Last Updated
October 12, 2015
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT02575716
Brief Title
Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant
Official Title
Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant
Detailed Description
Thirty-four patients with ASA classification I-II, who required oroendotracheal tube intubation, were studied in this prospective, double-blinded, randomized, clinical trial. Anesthesia was induced using fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg. Patients were randomly assigned to one of the two groups to receive either rocuronium 0.6 mg/kg or saline intravenously. The Mcgrath® VL intubation was initiated after 90s, when the patients were fully relaxed. The primary outcome was to compare tracheal intubating conditions between two groups. The secondary outcomes were the success rate in the first attempt intubation, time to intubation, the required propofol dose for intubation and anesthetic complications. Statistical analyses were performed using the R program version 2.14.2. The level of statistical significance was set at p < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Relaxant
Keywords
McGrath®, Videolaryngoscope, intubating condition, muscle relaxant, intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle relaxant
Arm Type
Experimental
Arm Description
Intubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg muscle relaxant use rocuronium 0.6 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg placebo use NSS 0.6 mg/kg
Intervention Type
Device
Intervention Name(s)
Videolaryngoscope
Intervention Description
Intubation with McGrath video laryngoscope after muscle relaxant
Primary Outcome Measure Information:
Title
Intubating condition.
Description
number of participants with 34 people
Time Frame
one year
Secondary Outcome Measure Information:
Title
Success rate in the first attempt intubation.
Time Frame
one year
Title
Time to intubation
Time Frame
One year
Title
The required propofol dose for intubation without muscle relaxant.
Time Frame
one year
Title
Events during the intubation attempts occurred.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-65 years old. ASA class I-II. Elective surgery required general anesthesia with oroendotracheal intubation Exclusion Criteria: Suspected or known difficult airway. Patient with risk of aspiration with required of rapid sequence induction . Plan remained intubation. Allergic to drugs used in the study. Renal or hepatic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piyaporn Vasinanukorn, MD.
Organizational Affiliation
Prince of Songklanagarind University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of anesthesiology
City
Hatyai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant

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