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| Name | Class |
|---|---|
| Hanoi Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Coughing During Extubation | Coughing during emergence will be assessed using a standardized cough grading scale:
| 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) | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Intraoperative Opioid Consumption | Total dose of fentanyl administered intraoperatively will be recorded. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thang Toan Nguyen, MD, PhD, Assoc Prof | Contact | +084916874795 | nguyentoanthang@hmu.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| Thang Toan Nguyen, MD, PhD, Assoc Prof | Bach Mai Hospital, Hanoi, Vietnam. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital | Recruiting | Hanoi | Vietnam |
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.
Beginning 6 months after publication and ending 24 months after publication.
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.
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D000071257 | Emergence Delirium |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Double-blind (Participant, Outcome Assessor)
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| Standard General Anesthesia | Procedure | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 24 hours after surgery |
| Postoperative Bleeding or Cervical Hematoma | Any clinically significant bleeding or cervical hematoma requiring intervention will be recorded. | Within 24 hours after surgery |
| Propofol consumption for induction | Propofol consumption for induction guided by BIS | During induction |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |