Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

NCT07462195 | Recruiting Phase 4

• 1 other identifier: DEX-THYROID-RCT-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Diseases

Keywords

Dexmedetomidine; Thyroidectomy; General Anesthesia; Extubation Cough; Emergence Agitation; Postoperative Nausea and Vomiting; Anesthetic Requirement; Quality of Recovery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Total Intraoperative Opioid Consumption

  During surgery

• Emergence Agitation

  During emergence and within the first 15 minutes in the PACU.

• Mean arterial pressure (mmHg)

  From induction to 10 minutes after extubation.

• Heart rate (beats per minute)

  From induction to 10 minutes after extubation.

• Postoperative Pain Intensity

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

Study Arms (2)

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.

Drug: Dexmedetomidine; Procedure: Standard General Anesthesia

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.

Procedure: Standard General Anesthesia

Interventions

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.

Dexmedetomidine Group

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.

Dexmedetomidine Group; Standard Anesthesia (Control Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bach Mai Hospital: lead
• Hanoi Medical University: collaborator

Study Sites (1)

Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital

Hanoi, Vietnam

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases; Emergence Delirium; Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Thang Toan Nguyen, MD, PhD, Assoc Prof

  Bach Mai Hospital, Hanoi, Vietnam.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thang Toan Nguyen, MD, PhD, Assoc Prof

CONTACT

+084916874795; nguyentoanthang@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Participant, Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 6 months after publication and ending 24 months after publication.
• 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.

Locations

VN (1)