Clinical trial NCT05420649: Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia
Official title: Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia With Combination of Superior Laryngeal Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spontaneous Breathing
Laryngomicrosurgery
Superior Laryngeal Nerve Block
Keywords: Nonintubated
Spontaneous breathing
Laryngomicrosurgery
Superior laryngeal nerve block
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PaCO2 after Laryngomicrosurgery
timeFrame: ABG was measured immediately after the end of LMS
Secondary outcomes:
measure: pH after Laryngomicrosurgery
timeFrame: ABG was measured immediately after the end of LMS
measure: Heart rate (HR)
timeFrame: during the LMS procedure
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Yuan Yi Chia, Director
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaohsiung Veterans General Hospital.
name: Yu Ting Kuo, physician
role: STUDY_DIRECTOR
affiliation: Kaohsiung Veterans General Hospital.
name: Ting Shou Chang, physician
role: STUDY_DIRECTOR
affiliation: Kaohsiung Veterans General Hospital.
name: Chih Chi Tsai, RA
role: STUDY_CHAIR
affiliation: Kaohsiung Veterans General Hospital.
name: Li-Ya Tseng, physician
role: STUDY_DIRECTOR
affiliation: Kaohsiung Veterans General Hospital.
name: Pei-Wen Shen, physician
role: STUDY_DIRECTOR
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