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

Muscle Relaxant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575716
• Other study ID #: PSU-561330812
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2015
• Last updated: October 12, 2015
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2015
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Hypotonia
• Muscle Relaxant

Intervention

Device:
• Videolaryngoscope
Intubation with McGrath video laryngoscope after muscle relaxant

Locations

Country	Name	City	State
Thailand	Department of anesthesiology	Hatyai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubating condition.	number of participants with 34 people	one year	No
Secondary	Success rate in the first attempt intubation.		one year	No
Secondary	Time to intubation		One year	No
Secondary	The required propofol dose for intubation without muscle relaxant.		one year	No
Secondary	Events during the intubation attempts occurred.		one year	No