Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery (DEX-THYROID)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Diseases
• Intervention / Treatment: Procedure: Standard General Anesthesia; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thang Toan Nguyen, MD, PhD, Assoc Prof; Phone Number: +084916874795; Email: nguyentoanthang@hmu.edu.vn

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Recruiting
    • Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
    • Contact: Thang Toan Nguyen; Phone Number: +084916874795; Email: nguyentoanthang@hmu.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Anesthesia (Control Group); 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; 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.
Experimental: Dexmedetomidine Group; 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.	Procedure: Standard General Anesthesia; 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.; Drug: Dexmedetomidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Bach Mai Hospital
• Collaborators: Hanoi Medical University
• Investigators: Principal Investigator: Thang Toan Nguyen, MD, PhD, Assoc Prof, Bach Mai Hospital, Hanoi, Vietnam.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Postoperative Nausea and Vomiting; Quality of Recovery; Thyroidectomy; General Anesthesia; Emergence Agitation; Extubation Cough; Anesthetic Requirement
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Thyroid Diseases; Postoperative Nausea and Vomiting; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: DEX-THYROID-RCT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after publication and ending 24 months after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No