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

NCT04680650 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• The times of movements or the times of spontaneous vocal cords activities

  If one of the following occurred, it would be seen as 1 "movement" and add 1 in the counting: (1) visually observed body movement, including bucking. (2) spontaneous vocal cords activity. (Spontaneous vocal cords activity due to insufficient neuromuscular blocking agents, a coarsening of the monitor baseline can be seen, with a series of small waveforms typically varying from 30 to 70 μV) .

  During the surgery

Study Arms (2)

Group DS

EXPERIMENTAL

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

Drug: Anesthesia was maintained with sevoflurane

Group DP

ACTIVE COMPARATOR

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

Drug: Anesthesia was maintained with propofol

Interventions

Anesthesia was maintained with sevoflurane 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 DS

Anesthesia was maintained with propofol 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.

Group DP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Di Liu

  Department of Anesthesiology，Cancer Center of Guangzhou Medical UniversityMedcial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: graduate student

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 23, 2020
• Study Start: April 30, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)