Evaluation the Efficiency of Intravenous Dexmedetomidine Under Nasal Humidification Rapid Ventilation Device Without Intubation in Laryngoscope Microsurgery

February 1, 2023 updated by: Yuan-Yi Chia, Kaohsiung Veterans General Hospital.

Method This single-center randomized-controlled trial is conducted to compare the efficiency of LMS with intubated general anesthesia(ITGA) and LMS with nonintubated anesthesia. The study also performed a comparative evaluation of the safety and feasibility of LMS with nonintubated general anesthesia under two different ventilation strategies. The investigators plan to enroll patients aged between 20 and 80 years who required LMS.

This study has divided into three groups: the first group was LMS patients receiving general intubation general anesthesia(ITGA group). The second group consisted of LMS patients who received non-intubated general anesthesia and performed SLNB(SLNB group). The third group was LMS patients who received non-intubated general anesthesia and were given Dexmedetomidine(Dex group)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background 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 carbon dioxide(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 comprehensively inspected and treated.

Current practice in LMS with nonintubated anesthesia is to perform superior laryngeal nerve block(SLNB) to help avoid bucking during the procedure. However, performing SLNB is an invasion procedure can lead to some complication such as bleeding, nerve injury or vessel injury.

Therefore, the investigators investigated the administration of dexmedetomidine with intravenous general anesthesia, it is can help the patient maintain spontaneous breathing, and provide higher surgical safety during LMS with nonintubated anesthesia.

Method This single-center randomized-controlled trial is conducted to compare the efficiency of LMS with intubated general anesthesia(ITGA) and LMS with nonintubated anesthesia. The study also performed a comparative evaluation of the safety and feasibility of LMS with nonintubated general anesthesia under two different ventilation strategies. The investigators plan to enroll patients aged between 20 and 80 years who required LMS.

This study has divided into three groups: the first group was LMS patients receiving general intubation general anesthesia(ITGA group). The second group consisted of LMS patients who received non-intubated general anesthesia and performed SLNB(SLNB group). The third group was LMS patients who received non-intubated general anesthesia and were given Dexmedetomidine(Dex group) The exclusion criteria were as follows: presence of severe airway obstruction, severe airway disease, American Society of anesthesiologists(ASA) physical state > III, pregnancy, or body mass index(BMI)≥40kg/m2.

This project is expected to improve the success rate of microlaryngoscopy in non-intubated anesthetized patients, in addition to the excellent surgical field and complete vocal cord examination, the use of dexmedetomidine instead of SLNB can provide good safety for non-intubated LMS .

Study Type

Interventional

Enrollment (Anticipated)

90

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 Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects are between 20-80 years old.
  • Patients undergoing laryngoscope microsurgery.
  • Anesthesiologists rated ASA as between I and III.

Exclusion Criteria:

  • Having drug dependence and drinking habits.
  • Abnormal heart, liver and kidney function.
  • Allergic reactions to narcotic drugs.
  • Emergency surgery.
  • pregnancy.
  • Refuse to participate.
  • 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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Intubated general anesthesia LMS
The patients received a LMS with intubated general anesthesia.
EXPERIMENTAL: Non-intubated LMS with spontaneous breathing
The patients received a non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.
Procedure: Non-intubated Laryngomicrosurgery
Non-intubated LMS was performed with assistance of Optiflow(HFNO).
EXPERIMENTAL: Non-intubated LMS with dexmedetomidine
The patient received a non-intubated LMS optiflow (HFNO) device and was administered dexmedetomidine.
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
arterial blood gas(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
PaO2 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
Hemodynamics data during LMS
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

  • Study Director: Yuan Yi Chia, Director, 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)

November 29, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (ACTUAL)

October 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSVGH22-CT8-38

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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