The Necessity of Routine Mask Ventilation in Adults

January 23, 2017 updated by: Yonsei University
The mask ventilation is a necessary procedure to provide oxygenation before the tracheal intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex, which is recently introduced, enables the use of high-dose muscle relaxant without concerning the delayed recovery of neuromuscular blockade. It seems that there is no need to perform the mask ventilation in adults with normal airway if the investigators use high-dose muscle relaxant for the anesthetic induction because adequate muscle relaxation can be achieved within 1-2 minutes. Therefore, the investigators hypothesized that routine mask ventilation is not needed in adult patients with normal airway. The investigators will compare the incidence of desaturation and gastric insufflation between the patients with mask ventilation and the patients without mask ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients of age over 20 years for scheduled surgery with more than one and a half hours under general anesthesia

Exclusion Criteria:

  • anticipated difficult mask ventilation,
  • anticipated difficult intubation,
  • ASA class 3 or 4,
  • preoperative saturation less than 92%.,
  • saturation less than 98% after preoxygenation
  • body mass index over 35 kg/m2,
  • obstructive sleep apnea,
  • mass in the oral cavity or in the trachea,
  • pregnant woman

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mask ventilation
Mask ventilation will be performed before the tracheal intubation.
Drug: Rocuronium
Procedure: mask ventilation
In mask ventilation group, rocuronium of 0.6 mg/kg will be administered after the loss of consciousness. Mask ventilation wil be performed until there is no response on the train-of-four stimulus. No mask ventilation - In no mask ventilation group, rocuronium of 1.2 mg/kg will be administered after the loss of consciousness. Tracheal intubation will be performed after confirmation of no response on the train-of-four stimulus. The mask ventilation will not be performed before the tracheal intubation.
Experimental: no mask ventilation
Mask ventilation will not be performed before the tracheal intubation.
Drug: Rocuronium
Procedure: no mask ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation (saturation less than 95%)
Time Frame: until 2 minutes after the completion of tracheal intubation
Primary outcome is the incidence of desaturation. Desaturation is defined as the saturation less than 95% which occurs after the anesthetic induction and before the first attempt of tracheal intubation.
until 2 minutes after the completion of tracheal intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric insufflation (observe the antral area of the stomach using ultrasonography)
Time Frame: until 2 minutes after the completion of tracheal intubation
Secondary outcome is the antral area of the stomach. We will observe the antral area of the stomach using ultrasonography.
until 2 minutes after the completion of tracheal intubation

Collaborators and Investigators

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

Sponsor

Yonsei 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 (Actual)

April 28, 2015

Primary Completion (Actual)

November 23, 2015

Study Completion (Actual)

November 23, 2015

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0036

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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