The Necessity of Routine Mask Ventilation in Adults

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Procedure: mask ventilation; Procedure: no mask ventilation; Drug: Rocuronium

• Registration Number: NCT02400931
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Study Start: 2015-04-28
• Primary Completion: 2015-11-23
• Study Completion: 2015-11-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mask ventilation	mask ventilation	Mask ventilation will be performed before the tracheal intubation.
no mask ventilation	no mask ventilation	Mask ventilation will not be performed before the tracheal intubation.
mask ventilation	Rocuronium	Mask ventilation will be performed before the tracheal intubation.
no mask ventilation	Rocuronium	Mask ventilation will not be performed before the tracheal intubation.

Primary Outcome Measures

Name	Time	Method
Desaturation (saturation less than 95%)	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.

Secondary Outcome Measures

Name	Time	Method
gastric insufflation (observe the antral area of the stomach using ultrasonography)	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of