Clinical trial NCT05253404: Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy
Official title: Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications, Pulmonary
Keywords: Extubation
Laryngeal mask
Craniotomies
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Hemodynamic
timeFrame: 30 minutes
measure: Pulmonary complications
timeFrame: 24 hours
measure: Partial pressure of carbon dioxide in arterial blood
timeFrame: 20 mins
Secondary outcomes:
measure: Re-do surgery
timeFrame: 24 hours
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Wei Cheng-Fong
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yung-Tai Chung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Cheng-Fong Wei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suppiah RK, Rajan S, Paul J, Kumar L. Respiratory and hemodynamic outcomes following exchange extubation with laryngeal mask airway as compared to traditional awake extubation. Anesth Essays Res. 2016 May-Aug;10(2):212-7. doi: 10.4103/0259-1162.174469.
citation: Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x.
citation: Wong TH, Weber G, Abramowicz AE. Smooth Extubation and Smooth Emergence Techniques: A Narrative Review. Anesthesiol Res Pract. 2021 Jan 15;2021:8883257. doi: 10.1155/2021/8883257. eCollection 2021.
citation: Juang J, Cordoba M, Ciaramella A, Xiao M, Goldfarb J, Bayter JE, Macias AA. Incidence of airway complications associated with deep extubation in adults. BMC Anesthesiol. 2020 Oct 29;20(1):274. doi: 10.1186/s12871-020-01191-8.