Dexmedetomidine to improve waking and reduce coughing after thyroid surgery
Effect of Perioperative Dexmedetomidine Infusion on Anesthetic Requirements and Quality of Emergence in Patients Undergoing Thyroid Surgery: A Randomized Controlled Trial
This will test whether giving dexmedetomidine from before anesthesia and continuing it during thyroid surgery reduces coughing, agitation, and the amount of anesthetic or opioid needed when waking up.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bach Mai Hospital Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT07462195 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective thyroidectomy under general anesthesia will be randomized to receive either a perioperative dexmedetomidine regimen (loading dose before induction and continuous infusion during surgery) plus standard balanced anesthesia or standard anesthesia alone. Standardized anesthetic induction, maintenance, and postoperative care protocols will be used to reduce variability. Key outcomes include intraoperative anesthetic and opioid consumption, coughing at extubation, emergence agitation, hemodynamic responses, postoperative nausea and vomiting, and bleeding-related complications. The study is a randomized, controlled, phase 4 trial conducted at Bach Mai Hospital.
Who should consider this trial
Good fit: Adults aged 18–65 with ASA physical status I–III scheduled for elective thyroidectomy who can provide informed consent and have no contraindication to dexmedetomidine.
Not a fit: Patients with severe cardiac conduction disease, severe hepatic or renal failure, those who are pregnant or breastfeeding, or those planned for postoperative ICU care are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce coughing and agitation during extubation, lower anesthetic and opioid requirements, and potentially decrease bleeding-related complications after thyroid surgery.
How similar studies have performed: Prior randomized trials using intraoperative or emergence-phase dexmedetomidine have shown reduced extubation coughing, blunted sympathetic responses, and improved recovery, though continuous perioperative dosing from induction through surgery is less commonly studied.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Hanoi
- Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Thang Toan Nguyen, MD, PhD, Assoc Prof — Bach Mai Hospital, Hanoi, Vietnam.
- Study coordinator: Thang Toan Nguyen, MD, PhD, Assoc Prof
- Email: nguyentoanthang@hmu.edu.vn
- Phone: +084916874795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.