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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04680650
Enrollment
66
Registered
2020-12-23
Start date
2020-04-30
Completion date
2021-03-31
Last updated
2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

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.

Interventions

DRUGAnesthesia 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.

DRUGAnesthesia 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.

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The times of movements or the times of spontaneous vocal cords activitiesDuring the surgeryIf 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) .

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026