The Necessity of Routine Mask Ventilation in Adults

Sponsors

Lead sponsor: Yonsei University

Source 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.

Overall Status Completed
Start Date April 28, 2015
Completion Date November 23, 2015
Primary Completion Date November 23, 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Desaturation (saturation less than 95%) until 2 minutes after the completion of tracheal intubation
Secondary Outcome
Measure Time Frame
gastric insufflation (observe the antral area of the stomach using ultrasonography) until 2 minutes after the completion of tracheal intubation
Enrollment 288
Condition
Intervention

Intervention type: Procedure

Intervention name: mask ventilation

Description: 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.

Arm group label: mask ventilation

Intervention type: Procedure

Intervention name: no mask ventilation

Arm group label: no mask ventilation

Intervention type: Drug

Intervention name: Rocuronium

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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Location Countries

Korea, Republic of

Verification Date

January 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: mask ventilation

Arm group type: Active Comparator

Description: Mask ventilation will be performed before the tracheal intubation.

Arm group label: no mask ventilation

Arm group type: Experimental

Description: Mask ventilation will not be performed before the tracheal intubation.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov