Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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 acc
• Процедура 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 accordi

Первичные конечные точки

• Incidence and Severity of Coughing During Extubation [Срок оценки: From suctioning of airway secretions until 5 minutes after extubation]
• Total Intraoperative Anesthetic Requirement [Срок оценки: During surgery]

Вторичные конечные точки (9)

• Total Intraoperative Opioid Consumption [Срок оценки: During surgery]
• Emergence Agitation [Срок оценки: During emergence and within the first 15 minutes in the PACU.]
• Mean arterial pressure (mmHg) [Срок оценки: From induction to 10 minutes after extubation.]
• Heart rate (beats per minute) [Срок оценки: From induction to 10 minutes after extubation.]
• Postoperative Pain Intensity [Срок оценки: PACU arrival; 1 hour; 6 hours; 12 hours; and 24 hours postoperatively.]
• Postoperative Nausea and Vomiting (PONV) [Срок оценки: Within 24 hours after surgery]
• Postoperative Recovery Quality [Срок оценки: 24 hours after surgery]
• Postoperative Bleeding or Cervical Hematoma [Срок оценки: Within 24 hours after surgery]
• Propofol consumption for induction [Срок оценки: During induction]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital — Hanoi

Идентификаторы

NCT: NCT07462195 · DEX-THYROID-RCT-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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