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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04680650
• Other study ID #: 01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2020
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Nodule

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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