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
About this trial
This is an interventional treatment trial for Muscle Relaxant focused on measuring McGrath®, Videolaryngoscope, intubating condition, muscle relaxant, intubation
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.
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
NCT ID
NCT02575716
First Posted
October 7, 2015
Last Updated
October 12, 2015
Sponsor
Prince of Songkla University
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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