The Necessity of Routine Mask Ventilation in Adults

NCT ID: NCT02400931

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-28
• Study Completion Date: 2015-11-23

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.

Conditions

General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

mask ventilation

Mask ventilation will be performed before the tracheal intubation.

Group Type: ACTIVE_COMPARATOR

mask ventilation

Intervention Type: PROCEDURE

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.

Rocuronium

Intervention Type: DRUG

no mask ventilation

Mask ventilation will not be performed before the tracheal intubation.

Group Type: EXPERIMENTAL

no mask ventilation

Intervention Type: PROCEDURE

Rocuronium

Intervention Type: DRUG

Interventions

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.

Intervention Type: PROCEDURE

no mask ventilation

Intervention Type: PROCEDURE

Rocuronium

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2015-0036

Identifier Type: -

Identifier Source: org_study_id