Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy
Primary Purpose
Thyroid Nodule
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anesthesia was maintained with sevoflurane
Anesthesia was maintained with propofol
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule
Eligibility Criteria
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.
Sites / Locations
- Cancer Center of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group DS
Group DP
Arm Description
Anesthesia was maintained with sevoflurane and target-controlled infusion of remifentanil in the group DS
Anesthesia was maintained with propofol and target-controlled infusion of remifentanil in the group DP
Outcomes
Primary Outcome Measures
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) .
Secondary Outcome Measures
Full Information
NCT ID
NCT04680650
First Posted
December 11, 2020
Last Updated
December 17, 2020
Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04680650
Brief Title
Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy
Official Title
Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group DS
Arm Type
Experimental
Arm Description
Anesthesia was maintained with sevoflurane and target-controlled infusion of remifentanil in the group DS
Arm Title
Group DP
Arm Type
Active Comparator
Arm Description
Anesthesia was maintained with propofol and target-controlled infusion of remifentanil in the group DP
Intervention Type
Drug
Intervention Name(s)
Anesthesia was maintained with sevoflurane
Intervention Description
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
Intervention Name(s)
Anesthesia was maintained with propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The times of movements or the times of spontaneous vocal cords activities
Description
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) .
Time Frame
During the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Di Liu
Organizational Affiliation
Department of Anesthesiology,Cancer Center of Guangzhou Medical UniversityMedcial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Six months after the completion of the study, original data can be obtained from the study's corresponding author.
Learn more about this trial
Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy
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