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OpenTrials
Completed

NCT Number: NCT02400931

The Necessity of Routine Mask Ventilation in Adults

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.

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Key information

Conditions

General Anesthesia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mask ventilation

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.

no mask ventilation

Procedure

Rocuronium

Drug

Primary outcomes

  1. Desaturation (saturation less than 95%)

    Time frame: until 2 minutes after the completion of tracheal intubation

    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.

Secondary outcomes

  1. gastric insufflation (observe the antral area of the stomach using ultrasonography)

    Time frame: until 2 minutes after the completion of tracheal intubation

    Secondary outcome is the antral area of the stomach. We will observe the antral area of the stomach using ultrasonography.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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