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The Necessity of Routine Mask Ventilation in Adults

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Yonsei University

Status

Completed

Conditions

General Anesthesia

Treatments

Drug: Rocuronium
Procedure: mask ventilation
Procedure: no mask ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT02400931
4-2015-0036

Details and patient eligibility

About

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.

Enrollment

288 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

288 participants in 2 patient groups

mask ventilation
Active Comparator group
Description:
Mask ventilation will be performed before the tracheal intubation.
Treatment:
Drug: Rocuronium
Procedure: mask ventilation
no mask ventilation
Experimental group
Description:
Mask ventilation will not be performed before the tracheal intubation.
Treatment:
Drug: Rocuronium
Procedure: no mask ventilation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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