MedDataX Logo

Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy

NCT ID: NCT04680650

Last Updated: 2020-12-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2021-03-31

Brief Summary

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

According to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (EMG) signal and lower obtained signal amplitude. In this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. The investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce the movement or spontaneous activity of vocal cords in patients and without affecting the EMG signals.

Detailed Description

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

Recurrent laryngeal nerve (RLN) injury is one of the most serious common complications in thyroid operation. Compared with the traditional operation under direct eye vision alone, application of intraoperative neural monitoring (IONM) is able to help surgeon in identifying the RLN during thyroid dissection, and enabling continuous monitoring of the neurological function during operation, thus reducing the incidence of intraoperative RLN injury. Sevoflurane is a common inhaled anesthetic in clinical practice, with the effect of prolonging the action time of muscle relaxants. According to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (EMG) signal and lower obtained signal amplitude, which may affect the surgeon's judgment on neurological function during the operation. In this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. The investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce movement or spontaneous activity of vocal cords in patients without affecting the IONM signal.

Conditions

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

Thyroid Nodule

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

DOUBLE

Participants Investigators

Study Groups

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

Group DS

Anesthesia was maintained with sevoflurane and target-controlled infusion of remifentanil in the group DS

Group Type EXPERIMENTAL

Anesthesia was maintained with sevoflurane

Intervention Type DRUG

After endotracheal intubation, anesthesia was maintained with 1.5-3% sevoflurane, 0.3-0.5 μg/kg/h dexmedetomidine and 2-4 μg/mL target-controlled infusion of remifentanil in the group DS.

Group DP

Anesthesia was maintained with propofol and target-controlled infusion of remifentanil in the group DP

Group Type ACTIVE_COMPARATOR

Anesthesia was maintained with propofol

Intervention Type DRUG

After endotracheal intubation, anesthesia was maintained with 2-4 μg/mL target-controlled infusion of propofol, 0.3-0.5 μg/kg/h dexmedetomidine and 2-4 μg/mL target-controlled infusion of remifentanil in the group DP.

Interventions

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

Anesthesia was maintained with sevoflurane

After endotracheal intubation, anesthesia was maintained with 1.5-3% sevoflurane, 0.3-0.5 μg/kg/h dexmedetomidine and 2-4 μg/mL target-controlled infusion of remifentanil in the group DS.

Intervention Type DRUG

Anesthesia was maintained with propofol

After endotracheal intubation, anesthesia was maintained with 2-4 μg/mL target-controlled infusion of propofol, 0.3-0.5 μg/kg/h dexmedetomidine and 2-4 μg/mL target-controlled infusion of remifentanil in the group DP.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* patients scheduled for thyroidectomy under general anesthesia
* American Society of Anesthesiologists (ASA) grade of I or II
* aged 18 to 65 years
* body mass index (BMI) \< 32 kg/m2.

Exclusion Criteria

* patients with RLN or vagus nerve injury were identified preoperatively
* severe cardiovascular, pulmonary, liver and kidney diseases
* history of allergy to narcotic include rocuronium -pregnancy or lactation-
* history or current usage of medication which may interfere neuromuscular transmission;
* family or personal history of malignant hyperthermia
* myasthenia gravis
* potential risk of airway difficulty
* unable to cooperate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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

OliviaLiu

graduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Di Liu

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology，Cancer Center of Guangzhou Medical UniversityMedcial

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01

Identifier Type: -

Identifier Source: org_study_id