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NCT Number: NCT07462195

Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

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.

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Key information

Conditions

Thyroid Diseases Confusion Delirium Emergence Delirium Endocrine System Diseases Mental Disorders Nausea Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital

Hanoi, Vietnam

Location status: Recruiting

Location contact

Thang Toan Nguyen

CONTACT

[email protected]

+084916874795

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence and Severity of Coughing During Extubation

    Time frame: From suctioning of airway secretions until 5 minutes after 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.

  2. Total Intraoperative Anesthetic Requirement

    Time frame: During surgery

    Total dose of anesthetic agents used during maintenance of anesthesia will be recorded, including:

    Volatile anesthetic concentration (MAC equivalents)

Secondary outcomes

  1. Total Intraoperative Opioid Consumption

    Time frame: During surgery

    Total dose of fentanyl administered intraoperatively will be recorded.

  2. Emergence Agitation

    Time frame: During emergence and within the first 15 minutes in the PACU.

    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.

  3. Mean arterial pressure (mmHg)

    Time frame: From induction to 10 minutes after extubation.

    Mean arterial pressure (mmHg) measured at induction, intubation, surgical incision, end of surgery, extubation, and 10 minutes after extubation.

  4. Heart rate (beats per minute)

    Time frame: From induction to 10 minutes after extubation.

    Heart rate (beats per minute) measured at induction, intubation, surgical incision, end of surgery, extubation, and 10 minutes after extubation.

  5. Postoperative Pain Intensity

    Time frame: PACU arrival; 1 hour; 6 hours; 12 hours; and 24 hours postoperatively.

    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.

  6. Postoperative Nausea and Vomiting (PONV)

    Time frame: Within 24 hours after surgery

    Incidence of nausea or vomiting and requirement for antiemetic therapy will be recorded.

  7. Postoperative Recovery Quality

    Time frame: 24 hours after surgery

    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.

  8. Postoperative Bleeding or Cervical Hematoma

    Time frame: Within 24 hours after surgery

    Any clinically significant bleeding or cervical hematoma requiring intervention will be recorded.

  9. Propofol consumption for induction

    Time frame: During induction

    Propofol consumption for induction guided by BIS

Study contacts

Contact information is provided by the study sponsor or research team.

Thang Toan Nguyen, MD, PhD, Assoc Prof

CONTACT

[email protected]

+084916874795

Sponsors and collaborators

Lead sponsor

Bach Mai Hospital

Other

Collaborators

  • Hanoi Medical University

Registry information

Official study title

Effect of Perioperative Dexmedetomidine Infusion on Anesthetic Requirements and Quality of Emergence in Patients Undergoing Thyroid Surgery: A Randomized Controlled Trial

Acronym: DEX-THYROID

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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