Thyroid DiseasesPhase 4DEX-THYROIDNCT07462195
Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery
A Phase 4 study testing Dexmedetomidine and Standard General Anesthesia in people with Thyroid Diseases, run by Bach Mai Hospital at 1 site in Vietnam.
Trial summary
Thyroid surgery requires smooth emergence from anesthesia to minimize coughing, hemodynamic fluctuations, and agitation during extubation, which may contribute to postoperative complications such as bleeding or cervical hematoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- Dexmedetomidine and Standard General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Apr 2026to 30 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective thyroid surgery (thyroidectomy) under general anesthesia with endotracheal intubation.
- Able to understand the study procedures and provide written informed consent.
Who cannot join
- Known hypersensitivity or contraindication to dexmedetomidine or study-related medications.
- Clinically significant cardiac conduction abnormality or arrhythmia (e.g., second- or third-degree atrioventricular block without a pacemaker), severe bradyarrhythmia, or unstable cardiovascular disease.
- Severe hepatic dysfunction or severe renal failure.
- Pregnancy or breastfeeding.
- Planned postoperative ICU admission or postoperative deterioration requiring ICU admission.
- Major intraoperative complications (e.g., major bleeding requiring urgent hemostatic intervention, tracheal or esophageal injury, or recurrent laryngeal nerve injury identified intraoperatively).
- Any condition that, in the investigator's judgment, would interfere with outcome assessment or increase risk (e.g., inability to reliably report pain scores or complete QoR-15).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
Hanoi
Thang Toan Nguyen, +084916874795, nguyentoanthang@hmu.edu.vn
About this study
Official title: Effect of Perioperative Dexmedetomidine Infusion on Anesthetic Requirements and Quality of Emergence in Patients Undergoing Thyroid Surgery: A Randomized Controlled Trial
Thyroid surgery requires smooth emergence from anesthesia to minimize coughing, hemodynamic fluctuations, and agitation during extubation, which may contribute to postoperative complications such as bleeding or cervical hematoma. Dexmedetomidine, a selective α2-adrenergic receptor agonist, has sedative, analgesic-sparing, and sympatholytic properties that may improve anesthetic stability and recovery quality.
This randomized controlled trial aims to evaluate the effectiveness of a continuous perioperative dexmedetomidine regimen initiated at induction of anesthesia and maintained during thyroid surgery.
Read more
The study will compare dexmedetomidine combined with standard balanced anesthesia versus standard anesthesia alone in terms of anesthetic requirements and emergence quality.
The primary hypothesis is that perioperative dexmedetomidine administration reduces anesthetic and opioid requirements and improves emergence quality by decreasing coughing during extubation and hemodynamic responses.
Read the detailed description
Dexmedetomidine has been widely studied as an anesthetic adjunct due to its sedative and analgesic-sparing effects without significant respiratory depression. Previous randomized trials have demonstrated its ability to reduce coughing during extubation, attenuate sympathetic responses, and improve recovery quality after thyroid surgery. However, most studies have administered dexmedetomidine only during emergence or intraoperatively.
This study investigates a comprehensive perioperative dexmedetomidine protocol consisting of:
- A loading dose immediately before induction of anesthesia
- Continuous infusion during surgery The aim is to assess whether this regimen improves intraoperative anesthetic efficiency and postoperative recovery quality.
Patients scheduled for thyroid surgery under general anesthesia will be randomized to receive dexmedetomidine or standard anesthesia without dexmedetomidine. Standardized anesthetic techniques will be used for induction, maintenance, and postoperative care.
Outcome measures include anesthetic requirements, opioid consumption, coughing at extubation, emergence agitation, hemodynamic responses, postoperative nausea and vomiting (PONV), and postoperative bleeding complications.
- Conditions
- Thyroid Diseases
- Being tested
- Dexmedetomidine, Standard General Anesthesia
- Keywords
- Dexmedetomidine, Thyroidectomy, General Anesthesia, Extubation Cough, Emergence Agitation, Postoperative Nausea and Vomiting, Anesthetic Requirement, Quality of Recovery
- Medical subject headings
- Thyroid Diseases, Emergence Delirium, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine administered perioperatively as an anesthetic adjunct. A loading dose of 1 µg/kg is infused immediately before induction of anesthesia (in 10 minutes), followed by continuous infusion at 0.5 µg/kg/h during surgery. Depth of anesthesia is monitored using bispectral index (BIS), and volatile anesthetic concentration is titrated to a target BIS range (40-60). Neuromuscular blockade is monitored using train-of-four (TOF) stimulation, and neuromuscular blocking agents are titrated accordingly, with extubation performed after standard neuromuscular recovery criteria are met.
Standard General AnesthesiaProcedure or surgery
Standardized balanced general anesthesia using intravenous induction with propofol, opioid analgesia, and neuromuscular blockade, followed by maintenance with inhalational anesthetic agents according to institutional practice. Depth of anesthesia is monitored using bispectral index (BIS), and volatile anesthetic concentration is titrated to a target BIS range (40-60). Neuromuscular blockade is monitored using train-of-four (TOF) stimulation, and neuromuscular blocking agents are titrated accordingly, with extubation performed after standard neuromuscular recovery criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Participants receive dexmedetomidine in addition to standardized general anesthesia. Dexmedetomidine is administered as a loading dose of 1 µg/kg during induction of anesthesia (in 10 minutes), followed by continuous infusion at 0.5 µg/kg/h throughout surgery. Receives: Drug: Dexmedetomidine; Procedure: Standard General Anesthesia |
| Standard Anesthesia (Control Group) | Active comparator | Participants receive standardized general anesthesia without dexmedetomidine. Anesthesia is induced with propofol, opioid analgesia, and neuromuscular blockade, and maintained using inhalational anesthetic agents according to institutional practice. Receives: Procedure: Standard General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Coughing During Extubation
Coughing during emergence will be assessed using a standardized cough grading scale:
- Grade 0: No cough
- Grade 1: Single cough
- Grade 2: Cough lasting ≤5 seconds
- Grade 3: Sustained cough >5 seconds or severe coughing The incidence and severity of cough will be recorded.
Measured: From suctioning of airway secretions until 5 minutes after extubation
Total Intraoperative Anesthetic Requirement
Total dose of anesthetic agents used during maintenance of anesthesia will be recorded, including:
Volatile anesthetic concentration (MAC equivalents)
Measured: During surgery
Secondary outcomes (9)
Total Intraoperative Opioid Consumption
Total dose of fentanyl administered intraoperatively will be recorded.
Measured: During surgery
Emergence Agitation
Emergence agitation severity will be assessed using Aono's Four-Point Agitation Scale. The scale ranges from 1 to 4, where 1 indicates calm, 2 indicates not calm but easily consoled, 3 indicates moderate agitation or restlessness and not easily calmed, and 4 indicates severe agitation with combative, excited, or disoriented behavior. Higher scores indicate worse emergence agitation.
Measured: During emergence and within the first 15 minutes in the PACU.
Mean arterial pressure (mmHg)
Mean arterial pressure (mmHg) measured at induction, intubation, surgical incision, end of surgery, extubation, and 10 minutes after extubation.
Measured: From induction to 10 minutes after extubation.
Heart rate (beats per minute)
Heart rate (beats per minute) measured at induction, intubation, surgical incision, end of surgery, extubation, and 10 minutes after extubation.
Measured: From induction to 10 minutes after extubation.
Postoperative Pain Intensity
Pain intensity assessed using the Visual Analog Scale for pain, 0-10 cm , where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate worse pain. Assessed at PACU arrival, 1 hour, 6 hours, 12 hours, and 24 hours postoperatively.
Measured: PACU arrival; 1 hour; 6 hours; 12 hours; and 24 hours postoperatively.
Postoperative Nausea and Vomiting (PONV)
Incidence of nausea or vomiting and requirement for antiemetic therapy will be recorded.
Measured: Within 24 hours after surgery
Postoperative Recovery Quality
Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery. The questionnaire will be completed 24 hours after surgery.
Measured: 24 hours after surgery
Postoperative Bleeding or Cervical Hematoma
Any clinically significant bleeding or cervical hematoma requiring intervention will be recorded.
Measured: Within 24 hours after surgery
Propofol consumption for induction
Propofol consumption for induction guided by BIS
Measured: During induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start13 Apr 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bach Mai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University
- Responsible party
- Principal investigator, Nguyen Toan Thang, Bach Mai Hospital
- Investigators
- Thang Toan Nguyen, MD, PhD, Assoc Prof, Principal investigator, Bach Mai Hospital, Hanoi, Vietnam.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462195
- Sponsor's protocol ID
- DEX-THYROID-RCT-2025
- Acronym
- DEX-THYROID
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results, along with the study protocol and statistical analysis plan, will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Dexmedetomidine Infusion on Anesthetic Requirements and Quality of Emergence in Patients Undergoing Thyroid Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07462195
- Acronym / sponsor ID
- DEX-THYROID / DEX-THYROID-RCT-2025
- Conditions
- Thyroid Diseases
- Keywords
- Dexmedetomidine, Thyroidectomy, General Anesthesia, Extubation Cough, Emergence Agitation, Postoperative Nausea and Vomiting, Anesthetic Requirement, Quality of Recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bach Mai HospitalUniversity, hospital or other
- Collaborators
- Hanoi Medical University
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
Thyroid surgery requires smooth emergence from anesthesia to minimize coughing, hemodynamic fluctuations, and agitation during extubation, which may contribute to postoperative complications such as bleeding or cervical hematoma. Dexmedetomidine, a selective α2-adrenergic receptor agonist, has sedative, analgesic-sparing, and sympatholytic properties that may improve anesthetic stability and recovery quality.
This randomized controlled trial aims to evaluate the effectiveness of a continuous perioperative dexmedetomidine regimen initiated at induction of anesthesia and maintained during thyroid surgery.
The study will compare dexmedetomidine combined with standard balanced anesthesia versus standard anesthesia alone in terms of anesthetic requirements and emergence quality.
The primary hypothesis is that perioperative dexmedetomidine administration reduces anesthetic and opioid requirements and improves emergence quality by decreasing coughing during extubation and hemodynamic responses.
Detailed description
Dexmedetomidine has been widely studied as an anesthetic adjunct due to its sedative and analgesic-sparing effects without significant respiratory depression. Previous randomized trials have demonstrated its ability to reduce coughing during extubation, attenuate sympathetic responses, and improve recovery quality after thyroid surgery. However, most studies have administered dexmedetomidine only during emergence or intraoperatively.
This study investigates a comprehensive perioperative dexmedetomidine protocol consisting of:
- A loading dose immediately before induction of anesthesia
- Continuous infusion during surgery The aim is to assess whether this regimen improves intraoperative anesthetic efficiency and postoperative recovery quality.
Patients scheduled for thyroid surgery under general anesthesia will be randomized to receive dexmedetomidine or standard anesthesia without dexmedetomidine. Standardized anesthetic techniques will be used for induction, maintenance, and postoperative care.
Outcome measures include anesthetic requirements, opioid consumption, coughing at extubation, emergence agitation, hemodynamic responses, postoperative nausea and vomiting (PONV), and postoperative bleeding complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine, Procedure: Standard General AnesthesiaParticipants receive dexmedetomidine in addition to standardized general anesthesia. Dexmedetomidine is administered as a loading dose of 1 µg/kg during induction of anesthesia (in 10 minutes), followed by continuous infusion at 0.5 µg/kg/h throughout surgery. |
| Standard Anesthesia (Control Group) | Active comparator | Procedure: Standard General AnesthesiaParticipants receive standardized general anesthesia without dexmedetomidine. Anesthesia is induced with propofol, opioid analgesia, and neuromuscular blockade, and maintained using inhalational anesthetic agents according to institutional practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective thyroid surgery (thyroidectomy) under general anesthesia with endotracheal intubation.
- Able to understand the study procedures and provide written informed consent.
Key exclusion criteria (7 listed)
- Known hypersensitivity or contraindication to dexmedetomidine or study-related medications.
- Clinically significant cardiac conduction abnormality or arrhythmia (e.g., second- or third-degree atrioventricular block without a pacemaker), severe bradyarrhythmia, or unstable cardiovascular disease.
- Severe hepatic dysfunction or severe renal failure.
- Pregnancy or breastfeeding.
- Planned postoperative ICU admission or postoperative deterioration requiring ICU admission.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine administered perioperatively as an anesthetic adjunct. A loading dose of 1 µg/kg is infused immediately before induction of anesthesia (in 10 minutes), followed by continuous infusion at 0.5 µg/kg/h during surgery. Depth of anesthesia is monitored using bispectral index (BIS), and volatile anesthetic concentration is titrated to a target BIS range (40-60). Neuromuscular blockade is monitored using train-of-four (TOF) stimulation, and neuromuscular blocking agents are titrated accordingly, with extubation performed after standard neuromuscular recovery criteria are met. | Drug | Dexmedetomidine Group |
| Standard General AnesthesiaStandardized balanced general anesthesia using intravenous induction with propofol, opioid analgesia, and neuromuscular blockade, followed by maintenance with inhalational anesthetic agents according to institutional practice. Depth of anesthesia is monitored using bispectral index (BIS), and volatile anesthetic concentration is titrated to a target BIS range (40-60). Neuromuscular blockade is monitored using train-of-four (TOF) stimulation, and neuromuscular blocking agents are titrated accordingly, with extubation performed after standard neuromuscular recovery criteria are met. | Procedure or surgery | Dexmedetomidine Group, Standard Anesthesia (Control Group) |
Primary outcome
Incidence and Severity of Coughing During Extubation
Time frame: From suctioning of airway secretions until 5 minutes after extubation
Coughing during emergence will be assessed using a standardized cough grading scale: * Grade 0: No cough * Grade 1: Single cough * Grade 2: Cough lasting ≤5 seconds * Grade 3: Sustained cough >5 seconds or severe coughing The incidence and severity of cough will be recorded.
Total Intraoperative Anesthetic Requirement
Time frame: During surgery
Total dose of anesthetic agents used during maintenance of anesthesia will be recorded, including: Volatile anesthetic concentration (MAC equivalents)
9 secondary outcomes
Total Intraoperative Opioid Consumption
Time frame: During surgery
Emergence Agitation
Time frame: During emergence and within the first 15 minutes in the PACU.
Mean arterial pressure (mmHg)
Time frame: From induction to 10 minutes after extubation.
Heart rate (beats per minute)
Time frame: From induction to 10 minutes after extubation.
Postoperative Pain Intensity
Time frame: PACU arrival; 1 hour; 6 hours; 12 hours; and 24 hours postoperatively.
Postoperative Nausea and Vomiting (PONV)
Time frame: Within 24 hours after surgery
Postoperative Recovery Quality
Time frame: 24 hours after surgery
Postoperative Bleeding or Cervical Hematoma
Time frame: Within 24 hours after surgery
Propofol consumption for induction
Time frame: During induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results, along with the study protocol and statistical analysis plan, will be available upon reasonable request.
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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.
Thang Toan Nguyen, MD, PhD, Assoc Prof principal investigator
Bach Mai Hospital, Hanoi, Vietnam.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Standard General Anesthesia in people with Thyroid Diseases, run by Bach Mai Hospital at 1 site in Vietnam.
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 7 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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 Vietnam. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thang Toan Nguyen, MD, PhD, Assoc Prof (+084916874795, nguyentoanthang@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Coughing During Extubation (time frame: From suctioning of airway secretions until 5 minutes after extubation). The study lists 2 primary outcomes in all. 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 15 Apr 2026.