NCT02400931

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2015

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

March 23, 2015

Last Update Submit

January 23, 2017

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Desaturation (saturation less than 95%)

    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 Outcomes (1)

  • gastric insufflation (observe the antral area of the stomach using ultrasonography)

    until 2 minutes after the completion of tracheal intubation

Study Arms (2)

mask ventilation

ACTIVE COMPARATOR

Mask ventilation will be performed before the tracheal intubation.

Procedure: mask ventilationDrug: Rocuronium

no mask ventilation

EXPERIMENTAL

Mask ventilation will not be performed before the tracheal intubation.

Procedure: no mask ventilationDrug: Rocuronium

Interventions

mask ventilationPROCEDURE

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.

mask ventilation
no mask ventilationPROCEDURE
no mask ventilation
RocuroniumDRUG
mask ventilationno mask ventilation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 27, 2015

Study Start

April 28, 2015

Primary Completion

November 23, 2015

Study Completion

November 23, 2015

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

KR(1)