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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05420649
Enrollment
49
Registered
2022-06-15
Start date
2020-10-20
Completion date
2022-10-26
Last updated
2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngomicrosurgery, Spontaneous Breathing, Superior Laryngeal Nerve Block

Keywords

Nonintubated, Spontaneous breathing, Laryngomicrosurgery, Superior laryngeal nerve block

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.

Interventions

PROCEDURENon-intubated Laryngomicrosurgery

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

Sponsors

Kaohsiung Veterans General Hospital.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
PaCO2 after LaryngomicrosurgeryABG was measured immediately after the end of LMSABG was measured immediately after the end of LMS

Secondary

MeasureTime frameDescription
pH after LaryngomicrosurgeryABG was measured immediately after the end of LMSABG was measured immediately after the end of LMS
Heart rate (HR)during the LMS procedureHemodynamic data were measured every 5 minutes

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026