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Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

ConditionThyroid Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBach Mai Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine GroupExperimental treatment 2 interventions
Group B: Standard Anesthesia (Control Group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From suctioning of airway secretions until 5 minutes after extubation
2

Total Intraoperative Anesthetic Requirement

Total dose of anesthetic agents used during maintenance of anesthesia will be recorded, including: Volatile anesthetic concentration (MAC equivalents)

Time frame
During surgery

Secondary outcomes

1

Total Intraoperative Opioid Consumption

Total dose of fentanyl administered intraoperatively will be recorded.

Time frame
During surgery
2

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.

Time frame
During emergence and within the first 15 minutes in the PACU.
3

Mean arterial pressure (mmHg)

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

Time frame
From induction to 10 minutes after extubation.
4

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.

Time frame
From induction to 10 minutes after extubation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bach Mai Hospital

Lead sponsor

Hanoi Medical University

Collaborator

Source ClinicalTrials.gov
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