Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia

Sponsor

Kaohsiung Veterans General Hospital. (Other)

Overall Status

Completed

CT.gov ID

NCT05420649

Collaborator

(none)

Enrollment

Location

Arms

17.1

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. Administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. Therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during LMS with nonintubated anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Breathing Laryngomicrosurgery Superior Laryngeal Nerve Block	Procedure: Non-intubated Laryngomicrosurgery	N/A

Detailed Description

Laryngeal microsurgery (LMS) is among the most common operations in otolaryngology and typically requires general anesthesia administered through endotracheal tube intubation. Endotracheal tube intubation provides stable gas exchange, protects the airways by preventing secretions from falling into the lower respiratory tract, and enables the monitoring of parameters such as tidal volume and end-tidal CO2.

Nonintubated anesthesia applied in combination with transnasal humidified rapid-insufflation ventilatory exchange or high-flow nasal oxygen (HFNO) is another option for LMS. LMS with nonintubated anesthesia can avoid the complications caused by endotracheal tube intubation such as oral tissue trauma, tracheal trauma, and dental injury. Furthermore, LMS with nonintubated anesthesia can provide a clearer surgical field of vision that allows the vocal cords to be inspected and disposed of completely. Current practice in LMS with nonintubated anesthesia is to administer a muscle relaxant to help avoid bucking during the procedure. However, the administration of a muscle relaxant can lead to apnea and hypercapnia, which may negatively affect hemodynamics. Therefore, the investigators investigated the use of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia to help the patient maintain spontaneous breathing and provide higher surgical safety during LMS with nonintubated anesthesia.

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia With Combination of Superior Laryngeal Nerve Block

Actual Study Start Date :

Oct 20, 2020

Actual Primary Completion Date :

Mar 22, 2022

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Intubated general anesthesia LMS Patients received LMS with intubated general anesthesia
Experimental: Non-intubated LMS with apnea Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device.	Procedure: Non-intubated Laryngomicrosurgery Non-intubated LMS was performed with assistance of Optiflow (HFNO).
Experimental: Non-intubated LMS with spontaneous breathing Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.	Procedure: Non-intubated Laryngomicrosurgery Non-intubated LMS was performed with assistance of Optiflow (HFNO).

Arm

Intervention/Treatment

No Intervention: Intubated general anesthesia LMS

Patients received LMS with intubated general anesthesia

Experimental: Non-intubated LMS with apnea

Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device.

Procedure: Non-intubated Laryngomicrosurgery

Non-intubated LMS was performed with assistance of Optiflow (HFNO).

Experimental: Non-intubated LMS with spontaneous breathing

Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.

Procedure: Non-intubated Laryngomicrosurgery

Non-intubated LMS was performed with assistance of Optiflow (HFNO).

Outcome Measures

Primary Outcome Measures

PaCO2 after Laryngomicrosurgery [ABG was measured immediately after the end of LMS]
ABG was measured immediately after the end of LMS

Secondary Outcome Measures

pH after Laryngomicrosurgery [ABG was measured immediately after the end of LMS]
ABG was measured immediately after the end of LMS
Heart rate (HR) [during the LMS procedure]
Hemodynamic data were measured every 5 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient who needed to undergo LMS.

Exclusion Criteria:

Severe airway obstruction.
Severe airway disease.
American Society of anesthesiologists (ASA) physical state > III.
Pregnancy or body mass index (BMI) ≥ 40 kg/m2.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan	81362

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

Investigators

Principal Investigator: Yuan Yi Chia, Director, Kaohsiung Veterans General Hospital.
Study Director: Yu Ting Kuo, physician, Kaohsiung Veterans General Hospital.
Study Director: Ting Shou Chang, physician, Kaohsiung Veterans General Hospital.
Study Chair: Chih Chi Tsai, RA, Kaohsiung Veterans General Hospital.
Study Director: Li-Ya Tseng, physician, Kaohsiung Veterans General Hospital.
Study Director: Pei-Wen Shen, physician, Kaohsiung Veterans General Hospital.