NCT07462195 Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery
| NCT ID | NCT07462195 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bach Mai Hospital |
| Condition | Thyroid Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2026-04-13 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Contact & Investigator
Thang Toan Nguyen, MD, PhD, Assoc Prof
PRINCIPAL INVESTIGATOR
Bach Mai Hospital, Hanoi, Vietnam.
Frequently Asked Questions
Who can join the NCT07462195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Thyroid Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07462195 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07462195 currently recruiting?
Yes, NCT07462195 is actively recruiting participants. Contact the research team at nguyentoanthang@hmu.edu.vn for enrollment information.
Where is the NCT07462195 trial being conducted?
This trial is being conducted at Hanoi, Vietnam.
Who is sponsoring the NCT07462195 clinical trial?
NCT07462195 is sponsored by Bach Mai Hospital. The principal investigator is Thang Toan Nguyen, MD, PhD, Assoc Prof at Bach Mai Hospital, Hanoi, Vietnam.. The trial plans to enroll 100 participants.