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

October 25, 2023 updated by: Yuan-Yi Chia, Kaohsiung Veterans General Hospital.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaCO2 after Laryngomicrosurgery
Time Frame: ABG was measured immediately after the end of LMS
ABG was measured immediately after the end of LMS
ABG was measured immediately after the end of LMS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH after Laryngomicrosurgery
Time Frame: ABG was measured immediately after the end of LMS
ABG was measured immediately after the end of LMS
ABG was measured immediately after the end of LMS
Heart rate (HR)
Time Frame: during the LMS procedure
Hemodynamic data were measured every 5 minutes
during the LMS procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Yuan Yi Chia, Director, Kaohsiung Veterans General Hospital.
  • Study Director: Li-Ya Tseng, physician, Kaohsiung Veterans General Hospital.
  • Study Director: Pei-Wen Shen, physician, 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

October 26, 2022

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSVGH20-CT9-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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