Thyroid Surgery Intraoperative Nerve Monitoring (IONM) Recurrent Laryngeal Nerve Function Dexmedetomidine vs Midazolam (Anesthetic Agents)DEX-RLNNCT07195214
EFFECT OF DEXMEDETOMİDİNE ON RECURRENT LARYNGEAL NERVE MONİTORİNG: A COMPARATİVE STUDY WİTH MİDAZOLAM
An observational study of Thyroid Surgery Intraoperative Nerve Monitoring (IONM) Recurrent Laryngeal Nerve Function Dexmedetomidine vs Midazolam (Anesthetic Agents), run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated the effect of dexmedetomidine compared with midazolam on intraoperative monitoring of the recurrent laryngeal nerve during thyroid surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Surgery Intraoperative Nerve Monitoring (IONM) Recurrent Laryngeal Nerve Function Dexmedetomidine vs Midazolam (Anesthetic Agents)
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2025to 30 Jul 2025
- Phase
- Observational
- 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
Study population: The study population consisted of adult patients (aged 18-65 years) scheduled for elective thyroidectomy under general anesthesia with intraoperative nerve monitoring. All participants were ASA physical status I-II, had no pre-existing laryngeal nerve dysfunction, and provided written informed consent. Patients were recruited at Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital, Department of General Surgery.
Who may be able to join
- Adults aged 18-65 years Patients scheduled for elective thyroidectomy under general anesthesia American Society of Anesthesiologists (ASA) physical status I-II Planned use of intraoperative nerve monitoring (IONM) Provided written informed consent
Who cannot join
- Previous neck surgery or radiotherapy affecting recurrent laryngeal nerve anatomy Pre-existing vocal cord paralysis or laryngeal nerve dysfunction Severe cardiovascular disease (e.g., advanced heart block, uncontrolled hypertension) Severe hepatic or renal dysfunction Known allergy or contraindication to dexmedetomidine, midazolam, or study medications Pregnancy or breastfeeding Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine on Recurrent Laryngeal Nerve Monitoring: A Prospective Observational Comparative Study With Midazolam
This prospective observational study evaluated the effect of dexmedetomidine compared with midazolam on intraoperative monitoring of the recurrent laryngeal nerve during thyroid surgery. The main goal was to assess whether dexmedetomidine influences the time to identify the recurrent laryngeal nerve and the quality of nerve signals. Secondary outcomes included time to vagus nerve identification, intraoperative hemodynamic changes, extubation time, postoperative nausea and vomiting, sedation levels, and recovery parameters. A total of 60 adult patients undergoing thyroidectomy with intraoperative neuromonitoring were included. The findings are expected to guide anesthetic choices that optimize patient safety and surgical outcomes in thyroid operations.
Read the detailed description
This prospective observational study was conducted to investigate the effect of dexmedetomidine compared with midazolam on intraoperative monitoring of the recurrent laryngeal nerve (RLN) during thyroid surgery. Sixty adult patients scheduled for thyroidectomy under general anesthesia with intraoperative nerve monitoring were enrolled. Patients were allocated to receive either dexmedetomidine or midazolam as part of anesthesia induction. The primary objective was to compare the time required to identify the recurrent laryngeal nerve and the quality of electromyographic signals between the two groups. Secondary outcomes included time to vagus nerve identification, intraoperative hemodynamic changes such as bradycardia or hypotension, amplitude and latency of RLN signals, extubation time, postoperative nausea and vomiting, sedation scores, and length of stay in the post-anesthesia care unit. The study was approved by the Amasya University Non-Interventional Clinical Research Ethics Committee (Approval No: E-30640013-050.04-246788). Findings from this study may contribute to optimizing anesthetic protocols for thyroid surgery to improve patient safety and surgical outcomes.
- Keywords
- Thyroid surgery; intraoperative neuromonitoring (IONM); total intravenous anesthesia; dexmedetomidine; midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetotimidine | using dexmedetotimidine | |
| midazolam | uzing midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Identification of the Recurrent Laryngeal Nerve (minutes)
The interval between the start of intraoperative neuromonitoring and the successful identification of the recurrent laryngeal nerve during thyroidectomy. This measure evaluates whether dexmedetomidine or midazolam affects the speed of RLN identification.
Measured: Intraoperative period (from skin incision until RLN identification, typically within the first 60 minutes of surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start24 Feb 2025
- Primary completion28 May 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Surgery Intraoperative Nerve Monitoring (IONM) Recurrent Laryngeal Nerve Function Dexmedetomidine vs Midazolam (Anesthetic Agents)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195214
- Sponsor's protocol ID
- Se
- Other IDs
- E-30640013-050.04-246788
- Acronym
- DEX-RLN
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because of ethical considerations and local regulations. Only summarized and de-identified results will be published in scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Recurrent Laryngeal Nerve Monitoring: A Prospective Observational Comparative Study With Midazolam
- ClinicalTrials.gov ID
- NCT07195214
- Acronym / sponsor ID
- DEX-RLN / Se
- Keywords
- Thyroid surgery; intraoperative neuromonitoring (IONM); total intravenous anesthesia; dexmedetomidine; midazolam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Sep 2025 (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.
This prospective observational study evaluated the effect of dexmedetomidine compared with midazolam on intraoperative monitoring of the recurrent laryngeal nerve during thyroid surgery. The main goal was to assess whether dexmedetomidine influences the time to identify the recurrent laryngeal nerve and the quality of nerve signals. Secondary outcomes included time to vagus nerve identification, intraoperative hemodynamic changes, extubation time, postoperative nausea and vomiting, sedation levels, and recovery parameters. A total of 60 adult patients undergoing thyroidectomy with intraoperative neuromonitoring were included. The findings are expected to guide anesthetic choices that optimize patient safety and surgical outcomes in thyroid operations.
Detailed description
This prospective observational study was conducted to investigate the effect of dexmedetomidine compared with midazolam on intraoperative monitoring of the recurrent laryngeal nerve (RLN) during thyroid surgery. Sixty adult patients scheduled for thyroidectomy under general anesthesia with intraoperative nerve monitoring were enrolled. Patients were allocated to receive either dexmedetomidine or midazolam as part of anesthesia induction. The primary objective was to compare the time required to identify the recurrent laryngeal nerve and the quality of electromyographic signals between the two groups. Secondary outcomes included time to vagus nerve identification, intraoperative hemodynamic changes such as bradycardia or hypotension, amplitude and latency of RLN signals, extubation time, postoperative nausea and vomiting, sedation scores, and length of stay in the post-anesthesia care unit. The study was approved by the Amasya University Non-Interventional Clinical Research Ethics Committee (Approval No: E-30640013-050.04-246788). Findings from this study may contribute to optimizing anesthetic protocols for thyroid surgery to improve patient safety and surgical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetotimidine | – | –using dexmedetotimidine |
| midazolam | – | –uzing midazolam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients (aged 18-65 years) scheduled for elective thyroidectomy under general anesthesia with intraoperative nerve monitoring. All participants were ASA physical status I-II, had no pre-existing laryngeal nerve dysfunction, and provided written informed consent. Patients were recruited at Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital, Department of General Surgery.
Key inclusion criteria (1 listed)
- Adults aged 18-65 years Patients scheduled for elective thyroidectomy under general anesthesia American Society of Anesthesiologists (ASA) physical status I-II Planned use of intraoperative nerve monitoring (IONM) Provided written informed consent
Key exclusion criteria (1 listed)
- Previous neck surgery or radiotherapy affecting recurrent laryngeal nerve anatomy Pre-existing vocal cord paralysis or laryngeal nerve dysfunction Severe cardiovascular disease (e.g., advanced heart block, uncontrolled hypertension) Severe hepatic or renal dysfunction Known allergy or contraindication to dexmedetomidine, midazolam, or study medications Pregnancy or breastfeeding Refusal to participate or inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Identification of the Recurrent Laryngeal Nerve (minutes)
Time frame: Intraoperative period (from skin incision until RLN identification, typically within the first 60 minutes of surgery).
The interval between the start of intraoperative neuromonitoring and the successful identification of the recurrent laryngeal nerve during thyroidectomy. This measure evaluates whether dexmedetomidine or midazolam affects the speed of RLN identification.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because of ethical considerations and local regulations. Only summarized and de-identified results will be published in scientific journals.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Surgery Intraoperative Nerve Monitoring (IONM) Recurrent Laryngeal Nerve Function Dexmedetomidine vs Midazolam (Anesthetic Agents), run by Amasya University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Sep 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Identification of the Recurrent Laryngeal Nerve (minutes) (time frame: Intraoperative period (from skin incision until RLN identification, typically within the first 60 minutes of 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 26 Sep 2025.