A Phase 4 interventional study of Dexmedetomidine and Standard General Anesthesia in Thyroid Diseases, sponsored by Bach Mai Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Bach Mai Hospital · Phase 4, Interventional, and Treatment
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.
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:
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.
365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 198 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Bach Mai Hospital is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexmedetomidine · Procedure: Standard General Anesthesia
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.
Procedure: Standard General Anesthesia
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.
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.
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.
Time frame: 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)
Time frame: During surgery
Total Intraoperative Opioid Consumption
Total dose of fentanyl administered intraoperatively will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after surgery
Postoperative Bleeding or Cervical Hematoma
Any clinically significant bleeding or cervical hematoma requiring intervention will be recorded.
Time frame: Within 24 hours after surgery
Propofol consumption for induction
Propofol consumption for induction guided by BIS
Time frame: During induction
Plan to share: 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Beginning 6 months after publication and ending 24 months after publication.
Access criteria: Requests will be reviewed by the study investigators. Data will be shared for non-commercial research purposes following approval and execution of a data use agreement.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Oct 2026, 6 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexmedetomidine
Bach Mai Hospital