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

Not Applicable

Completed

• Conditions: Complications, Pulmonary
• Interventions: Device: Ambu® AuraOnce™ Disposable Laryngeal Mask

• Registration Number: NCT05253404
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-02-08
• Study Start: 2022-02-15
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-23
• Status Verified: 2022-09
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switching endotracheal tube to laryngeal mask	Ambu® AuraOnce™ Disposable Laryngeal Mask	When craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at 2.63%-2.97%, we perform suction secretions in endotracheal tube and oral cavity, then switching endotracheal tube to laryngeal mask. Then we discontinue inhalation anesthestic sevoflurane and support oxygen at the rate of 6L/min. At the same time, give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when sevofulrane at MAC 0.4, spontaneously generating tidal volume of \>4ml/kg, EtCO2\<45mmHg, Train of four ratio \>70-90%.

Primary Outcome Measures

Name	Time	Method
Pulmonary complications	24 hours	Rate of Participants with Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%\< 90%) and Need airway assist device(Nasal or oral airway)
Partial pressure of carbon dioxide in arterial blood	20 mins	Partial pressure of carbon dioxide in arterial blood five minutes before and after extubation
Hemodynamic	30 minutes	Blood pressure including systolic, diastolic and mean arterial pressure and heart rate during extubation

Secondary Outcome Measures

Name	Time	Method
Re-do surgery	24 hours	Number of Participants with Re-do neurosurgery within 24hours

Trial Locations

Locations (1)

Wei Cheng-Fong; 🇨🇳 Taoyuan City, Taiwan