Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:18 AM
Study NCT ID:
NCT07462195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind (Participant, Outcome Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Severity of Coughing During Extubation', 'timeFrame': 'From suctioning of airway secretions until 5 minutes after extubation', 'description': 'Coughing during emergence will be assessed using a standardized cough grading scale:\n\n* Grade 0: No cough\n* Grade 1: Single cough\n* Grade 2: Cough lasting ≤5 seconds\n* Grade 3: Sustained cough \\>5 seconds or severe coughing The incidence and severity of cough will be recorded.'}, {'measure': 'Total Intraoperative Anesthetic Requirement', 'timeFrame': 'During surgery', 'description': 'Total dose of anesthetic agents used during maintenance of anesthesia will be recorded, including:\n\nVolatile anesthetic concentration (MAC equivalents)'}], 'secondaryOutcomes': [{'measure': 'Total Intraoperative Opioid Consumption', 'timeFrame': 'During surgery', 'description': 'Total dose of fentanyl administered intraoperatively will be recorded.'}, {'measure': 'Emergence Agitation', 'timeFrame': 'During emergence and within the first 15 minutes in the PACU.', 'description': "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."}, {'measure': 'Mean arterial pressure (mmHg)', 'timeFrame': 'From induction to 10 minutes after extubation.', 'description': 'Mean arterial pressure (mmHg) measured at induction, intubation, surgical incision, end of surgery, extubation, and 10 minutes after extubation.'}, {'measure': 'Heart rate (beats per minute)', 'timeFrame': 'From induction to 10 minutes after extubation.', 'description': 'Heart rate (beats per minute) measured at induction, intubation, surgical incision, end of surgery, extubation, and 10 minutes after extubation.'}, {'measure': 'Postoperative Pain Intensity', 'timeFrame': 'PACU arrival; 1 hour; 6 hours; 12 hours; and 24 hours postoperatively.', 'description': '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.'}, {'measure': 'Postoperative Nausea and Vomiting (PONV)', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Incidence of nausea or vomiting and requirement for antiemetic therapy will be recorded.'}, {'measure': 'Postoperative Recovery Quality', 'timeFrame': '24 hours after surgery', 'description': '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.'}, {'measure': 'Postoperative Bleeding or Cervical Hematoma', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Any clinically significant bleeding or cervical hematoma requiring intervention will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Thyroidectomy', 'General Anesthesia', 'Extubation Cough', 'Emergence Agitation', 'Postoperative Nausea and Vomiting', 'Anesthetic Requirement', 'Quality of Recovery'], 'conditions': ['Thyroid Diseases']}, 'descriptionModule': {'briefSummary': '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.\n\nThis randomized controlled trial aims to evaluate the effectiveness of a continuous perioperative dexmedetomidine regimen initiated at induction of anesthesia and maintained until the post-anesthesia care unit (PACU), with an additional bolus before extubation, in patients undergoing thyroid surgery.\n\nThe study will compare dexmedetomidine combined with standard balanced anesthesia versus standard anesthesia alone in terms of anesthetic requirements and emergence quality.\n\nThe primary hypothesis is that perioperative dexmedetomidine administration reduces anesthetic and opioid requirements and improves emergence quality by decreasing coughing during extubation and hemodynamic responses.', 'detailedDescription': '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.\n\nThis study investigates a comprehensive perioperative dexmedetomidine protocol consisting of:\n\n* A loading dose at induction of anesthesia\n* Continuous infusion during surgery and into the PACU\n* A bolus dose prior to extubation The aim is to assess whether this extended regimen improves intraoperative anesthetic efficiency and postoperative recovery quality.\n\nPatients 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.\n\nOutcome measures include anesthetic requirements, opioid consumption, coughing at extubation, emergence agitation, hemodynamic responses, postoperative nausea and vomiting (PONV), and postoperative bleeding complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-65 years.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Scheduled for elective thyroid surgery (thyroidectomy) under general anesthesia with endotracheal intubation.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to dexmedetomidine or study-related medications.\n* Clinically significant cardiac conduction abnormality or arrhythmia (e.g., second- or third-degree atrioventricular block without a pacemaker), severe bradyarrhythmia, or unstable cardiovascular disease.\n* Severe hepatic dysfunction or severe renal failure.\n* Pregnancy or breastfeeding.\n* Planned postoperative ICU admission or postoperative deterioration requiring ICU admission.\n* Major intraoperative complications (e.g., major bleeding requiring urgent hemostatic intervention, tracheal or esophageal injury, or recurrent laryngeal nerve injury identified intraoperatively).\n* 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)."}, 'identificationModule': {'nctId': 'NCT07462195', 'acronym': 'DEX-THYROID', 'briefTitle': 'Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Bach Mai Hospital'}, 'officialTitle': 'Effect of Perioperative Dexmedetomidine Infusion on Anesthetic Requirements and Quality of Emergence in Patients Undergoing Thyroid Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '65/BM - HĐĐĐ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine Group', 'description': 'Participants receive dexmedetomidine in addition to standardized general anesthesia. Dexmedetomidine is administered as a loading dose of 1 µg/kg during induction of anesthesia, followed by continuous infusion at 0.5 µg/kg/h throughout surgery and into the post-anesthesia care unit (PACU), with an additional bolus dose of 0.5 µg/kg administered before extubation.', 'interventionNames': ['Drug: Dexmedetomidine', 'Procedure: Standard General Anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Anesthesia (Control Group)', 'description': '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.', 'interventionNames': ['Procedure: Standard General Anesthesia']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine administered perioperatively as an anesthetic adjunct. A loading dose of 1 µg/kg is infused during induction of anesthesia, followed by continuous infusion at 0.5 µg/kg/h during surgery and continued into the post-anesthesia care unit (PACU). An additional bolus dose of 0.5 µg/kg is administered before extubation. 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.', 'armGroupLabels': ['Dexmedetomidine Group']}, {'name': 'Standard General Anesthesia', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Dexmedetomidine Group', 'Standard Anesthesia (Control Group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Thang Toan Nguyen, MD, PhD, Assoc Prof', 'role': 'CONTACT', 'email': 'nguyentoanthang@hmu.edu.vn', 'phone': '+084916874795'}], 'overallOfficials': [{'name': 'Thang Toan Nguyen, MD, PhD, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bach Mai Hospital, Hanoi, Vietnam.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Beginning 6 months after publication and ending 24 months after publication.', 'ipdSharing': 'YES', '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bach Mai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanoi Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Consultant Anesthesiologist', 'investigatorFullName': 'Nguyen Toan Thang', 'investigatorAffiliation': 'Bach Mai Hospital'}}}}