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

October 12, 2015 updated by: Piyaporn Vasinanukorn, Prince of Songkla University
The objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Thailand
    • Songkla
      • Hatyai, Songkla, Thailand, 90110
        • Department of Anesthesiology

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Muscle relaxant
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
Device: Videolaryngoscope
Intubation with McGrath video laryngoscope after muscle relaxant
Placebo Comparator: Placebo
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
Device: Videolaryngoscope
Intubation with McGrath video laryngoscope after muscle relaxant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubating condition.
Time Frame: one year
number of participants with 34 people
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Success rate in the first attempt intubation.
Time Frame: one year
one year
Time to intubation
Time Frame: One year
One year
The required propofol dose for intubation without muscle relaxant.
Time Frame: one year
one year
Events during the intubation attempts occurred.
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

Investigators

  • Study Chair: Piyaporn Vasinanukorn, MD., Prince of Songklanagarind University

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

March 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 12, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSU-561330812

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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