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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05253404

Enrollment

Registered

2022-02-23

Start date

2022-02-15

Completion date

2022-09-09

Last updated

2022-09-14

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

Conditions

Complications, Pulmonary

Keywords

Extubation, Laryngeal mask, Craniotomies

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

Interventions

DEVICEAmbu® AuraOnce™ Disposable Laryngeal Mask

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%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Masking description

Participant will going general anesthesia

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hemodynamic	30 minutes	Blood pressure including systolic, diastolic and mean arterial pressure and heart rate during extubation
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

Secondary

Measure	Time frame	Description
Re-do surgery	24 hours	Number of Participants with Re-do neurosurgery within 24hours

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026