The Necessity of Routine Mask Ventilation in Adults

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400931
• Other study ID #: 4-2015-0036
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: January 23, 2017
• Start date: April 28, 2015
• Est. completion date: November 23, 2015

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: November 23, 2015
• Est. primary completion date: November 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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.
• no mask ventilation

Drug:
• Rocuronium

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	gastric insufflation (observe the antral area of the stomach using ultrasonography)	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