NCT02575716

Brief Summary

The objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

October 7, 2015

Last Update Submit

October 12, 2015

Conditions

Muscle Relaxant

Keywords

McGrath®Videolaryngoscopeintubating conditionmuscle relaxantintubation

Outcome Measures

Primary Outcomes (1)

  • Intubating condition.

    number of participants with 34 people

    one year

Secondary Outcomes (4)

  • Success rate in the first attempt intubation.

    one year

  • Time to intubation

    One year

  • The required propofol dose for intubation without muscle relaxant.

    one year

  • Events during the intubation attempts occurred.

    one year

Study Arms (2)

Muscle relaxant

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

VideolaryngoscopeDEVICE

Intubation with McGrath video laryngoscope after muscle relaxant

Muscle relaxantPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesiology

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Piyaporn Vasinanukorn, MD.

    Prince of Songklanagarind University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 15, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

TH(1)