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

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Drug: Anesthesia was maintained with sevoflurane; Drug: Anesthesia was maintained with propofol

• Registration Number: NCT04680650
• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-04-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-17
• Last Update Submitted: 2020-12-17
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group DS	Anesthesia was maintained with sevoflurane	Anesthesia was maintained with sevoflurane and target-controlled infusion of remifentanil in the group DS
Group DP	Anesthesia was maintained with propofol	Anesthesia was maintained with propofol and target-controlled infusion of remifentanil in the group DP

Primary Outcome Measures

Name	Time	Method
The times of movements or the times of spontaneous vocal cords activities	During the surgery	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) .

Trial Locations

Locations (1)

Cancer Center of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China