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

Study Overview
=================
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

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

Conditions
-----------------
Complications, Pulmonary

Intervention / Treatment
-----------------
* Device: Ambu® AuraOnce™ Disposable Laryngeal Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Anesthesia remove endotracheal tube<br>When craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at MAC 2-3%, at the same time we perform suction secretions in endotracheal tube and oral cavity and give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when spontaneously generating tidal volume of >4ml/kg, EtCO2<45mmHg, Train of four ratio >70-90%. | |
| Experimental: Switching endotracheal tube to laryngeal mask<br>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%. | Device: Ambu® AuraOnce™ Disposable Laryngeal Mask<br>* 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%.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-do surgery | Number of Participants with Re-do neurosurgery within 24hours | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extubation, Laryngeal mask, Craniotomies