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The Necessity of Routine Mask Ventilation in Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02400931
Enrollment
288
Registered
2015-03-27
Start date
2015-04-28
Completion date
2015-11-23
Last updated
2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

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.

Interventions

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.

PROCEDUREno mask ventilation
DRUGRocuronium

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Desaturation (saturation less than 95%)until 2 minutes after the completion of tracheal intubationPrimary 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

MeasureTime frameDescription
gastric insufflation (observe the antral area of the stomach using ultrasonography)until 2 minutes after the completion of tracheal intubationSecondary outcome is the antral area of the stomach. We will observe the antral area of the stomach using ultrasonography.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026