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Clinical Trials/NCT05420649
NCT05420649CompletedNot Applicable

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

Kaohsiung Veterans General Hospital.2 sites in 1 country49 target enrollmentStarted: October 20, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
49
Locations
2
Primary Endpoint
PaCO2 after Laryngomicrosurgery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

PaCO2 after Laryngomicrosurgery

Time Frame: ABG was measured immediately after the end of LMS

ABG was measured immediately after the end of LMS

Secondary Outcomes

  • Heart rate (HR)(during the LMS procedure)
  • pH after Laryngomicrosurgery(ABG was measured immediately after the end of LMS)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yuan-Yi Chia

Chief of Anesthesiology

Kaohsiung Veterans General Hospital.

Study Sites (2)

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