Home
Clinical Trials
Evaluation of the Feasibility...

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

NCT ID: NCT05420649

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-10-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neuromuscular Block Monitoring During Monitored Thyroidectomy

NCT04982185

Thyroid Surgery

COMPLETED

The Study of Bilateral Upper Laryngeal Nerve Block for Supporting the Removal of Vocal Cord Polyps Under Laryngoscopy

NCT05309174

Vocal Cord Polyp

UNKNOWN NA

Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE

NCT04247412

Vocal Polyp

UNKNOWN

Thermosoftening of Double-lumen Tube to Reduce Sore Throat

NCT01626365

Hoarseness Sore Throat Vocal Cord Injuries

COMPLETED NA

The Feasibility of Bilateral Intermediate Cervical Plexus Block for Thyroidectomy/Parathyroidectomy

NCT04905641

Parathyroid Adenoma Thyroid Nodule

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spontaneous Breathing Laryngomicrosurgery Superior Laryngeal Nerve Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intubated general anesthesia LMS

Patients received LMS with intubated general anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-intubated LMS with apnea

Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device.

Group Type EXPERIMENTAL

Non-intubated Laryngomicrosurgery

Intervention Type PROCEDURE

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

Non-intubated LMS with spontaneous breathing

Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.

Group Type EXPERIMENTAL

Non-intubated Laryngomicrosurgery

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-intubated Laryngomicrosurgery

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yuan-Yi Chia

Chief of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR