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

NCT05253404 | Completed DMC

• 1 other identifier: 202102115A3
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complications, Pulmonary

Keywords

Extubation; Laryngeal mask; Craniotomies

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Re-do surgery

  24 hours

Study Arms (2)

Anesthesia remove endotracheal tube

NO INTERVENTION

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%.

Switching endotracheal tube to laryngeal mask

EXPERIMENTAL

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

Interventions

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%.

Switching endotracheal tube to laryngeal mask

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Wei Cheng-Fong

Taoyuan, 333, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 27212749 BACKGROUND

• 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.

  PMID: 9709138 BACKGROUND

• 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.

  PMID: 33510786 BACKGROUND

• 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.

  PMID: 33121440 BACKGROUND

• Wei CF, Chung YT. Laryngeal mask airway facilitates a safe and smooth emergence from anesthesia in patients undergoing craniotomy: a prospective randomized controlled study. BMC Anesthesiol. 2023 Jan 17;23(1):29. doi: 10.1186/s12871-023-01972-x.

  PMID: 36650435 DERIVED

Study Officials

• Yung-Tai Chung, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Cheng-Fong Wei, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will going general anesthesia
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 23, 2022
• Study Start: February 15, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)