Skip to main content
OpenTrials
Completed

NCT Number: NCT05253404

Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy

Stabilizing hemodynamic and reducing pulmonary complications during extubation with switching endotracheal tube to laryngeal mask in craniotomies

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complications, Pulmonary

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wei Cheng-Fong

Taoyuan City, 333, Taiwan

About this study

recruit ASA: 1-3, 20-65 years old undergoing neurosurgery under general anesthesia Excluded 1.Decline to participated 2.Difficult airway 3.Body Mass Index >30 4. Pregnant woman 5.Nothing Per Os <8hrs(case number:80).

General anesthesia Induction: 0.15-0.2 mg/kg cisatracurium or 0.6-1.2mg rocuronium , 1.5-2 mg/kg propofol, 1-2 mcg/kg Fentanyl. Endotracheal tube 6.5-7.5mm. Maintenance with sevoflurane 2- 3% FiO2:100%. Optimal muscle tension monitor. When surgery done, sevoflurane at 2.63-2.97%

Then randomly assigned two group Anesthesia group(control group) : Removed endotracheal tube at sevoflurane at 2-3% Switching group (intervention group): Intervention with endotracheal tube to laryngeal mask, and removing laryngeal mask at sevoflurane: 0.4MAC

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA: 1-3, 20-65 years old undergoing craniotomies under general anesthesia

Exclusion criteria

  • Decline to participated
  • Difficult airway
  • Body Mass Index >30
  • Pregnant woman
  • Nothing Per Os <8hrs

Treatment and study plan

Ambu® AuraOnce™ Disposable Laryngeal Mask

Device

Switching endotracheal tube to laryngeal mask at sevoflurane 2.63-2.97%, Removing endotracheal tube when spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%.

Primary outcomes

  1. Hemodynamic

    Time frame: 30 minutes

    Blood pressure including systolic, diastolic and mean arterial pressure and heart rate during extubation

  2. Pulmonary complications

    Time frame: 24 hours

    Rate of Participants with Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%< 90%) and Need airway assist device(Nasal or oral airway)

  3. Partial pressure of carbon dioxide in arterial blood

    Time frame: 20 mins

    Partial pressure of carbon dioxide in arterial blood five minutes before and after extubation

Secondary outcomes

  1. Re-do surgery

    Time frame: 24 hours

    Number of Participants with Re-do neurosurgery within 24hours

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2022
Registry last updated
Sep 14, 2022

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.