Thyroid NoduleNCT04680650
Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy
A study testing Anesthesia was maintained with sevoflurane and Anesthesia was maintained with propofol in people with Thyroid Nodule, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Anesthesia was maintained with sevoflurane and Anesthesia was maintained with propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Thyroid Nodule
- Being tested
- Anesthesia was maintained with sevoflurane, Anesthesia was maintained with propofol
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia was maintained with sevofluraneDrug
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 propofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group DS | Experimental | Anesthesia was maintained with sevoflurane and target-controlled infusion of remifentanil in the group DS Receives: 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 Receives: Drug: Anesthesia was maintained with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start30 Apr 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OliviaLiu, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Investigators
- Di Liu, Principal investigator, Department of Anesthesiology，Cancer Center of Guangzhou Medical UniversityMedcial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680650
- Sponsor's protocol ID
- 01
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Six months after the completion of the study, original data can be obtained from the study's corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy
- ClinicalTrials.gov ID
- NCT04680650
- Acronym / sponsor ID
- 01
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DS | Experimental | Drug: Anesthesia was maintained with sevofluraneAnesthesia was maintained with sevoflurane and target-controlled infusion of remifentanil in the group DS |
| Group DP | Active comparator | Drug: Anesthesia was maintained with propofolAnesthesia was maintained with propofol and target-controlled infusion of remifentanil in the group DP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia was maintained with sevofluraneAfter 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. | Drug | Group DS |
| Anesthesia was maintained with propofolAfter 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. | Drug | Group DP |
Primary outcome
The times of movements or the times of spontaneous vocal cords activities
Time frame: 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) .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: No. Six months after the completion of the study, original data can be obtained from the study's corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Di Liu principal investigator
Department of Anesthesiology，Cancer Center of Guangzhou Medical UniversityMedcial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia was maintained with sevoflurane and Anesthesia was maintained with propofol in people with Thyroid Nodule, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The times of movements or the times of spontaneous vocal cords activities (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.