The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery

Официальное название

The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery: A Randomized Controlled Study.

Обзор

This study intends to implement esketamine-assisted anesthesia in patients undergoing non-inflatable transoral endoscopic thyroidectomy through a prospective randomized controlled trial, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients.

Вмешательства

• Препарат Esketamine（iv）
  During anesthesia induction, administer esketamine intravenously at 0.5 mg/kg. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray physiological saline (3 ml) above the glottis, at the glottis, and below the glottis.
• Препарат ESK spray
  During anesthesia induction, Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray esketamine at the supraglottic, glottic, and subglottic levels: 3 ml (0.5 mg/kg).
• Препарат Normal Saline
  During anesthesia induction, intravenous injection of an equal amount of normal saline is administered. After achieving muscle relaxation, under direct laryngoscopic view, spray normal saline over the supraglottic, glottic, and subglottic areas: 3 ml.

Первичные конечные точки

• Incidence of coughing during tracheal extubation [Срок оценки: Perioperative (From the awakening period to immediately after tracheal extubation)]

Вторичные конечные точки (12)

• Severity of coughing during tracheal extubation [Срок оценки: Perioperative (From the awakening period to immediately after tracheal extubation)]
• Agitation score during tube removal [Срок оценки: Perioperative (From the awakening period to immediately after tracheal extubation)]
• Blood pressure [Срок оценки: Perioperative (From the induction period until 5 minutes after the completion of surgery)]
• Airway pressure 5 minutes after intubation and at the end of surgery [Срок оценки: 5 minutes after intubation and at the end of the surgery.]
• Intraoperative use rate and dosage of vasoactive drugs [Срок оценки: Intraoperative (From the induction period to the end of anesthesia)]
• Intraoperative doses of sufentanil [Срок оценки: Intraoperative (From the induction period to the end of anesthesia)]
• Intraoperative fluid volume [Срок оценки: Intraoperative (From the induction period to the end of anesthesia)]
• Sore throat score [Срок оценки: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.]
• Surgical area pain scores [Срок оценки: Postoperative 24 hours and 48 hours.]
• Incidence of adverse reactions [Срок оценки: Within 48 hours after surgery]
• Postoperative nausea and vomiting(PONV) score [Срок оценки: Within 48 hours after surgery.]
• Postoperative analgesic dosage [Срок оценки: Within day 2 after surgery]

Критерии участия

Критерии включения

• Patients scheduled for endotracheal intubation-free thyroid surgery under oral endoscopy
• ASA class I-II
• Voluntarily participate in the study and sign the informed consent form

Критерии исключения

• Body Mass Index > 30 kg/m²
• Patients with unstable ischemic cardiomyopathy, pulmonary hypertension, poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure >180/100 mmHg)
• Hepatic or renal dysfunction
• History of oral, maxillofacial, neck, or airway surgery, or pathological structural alterations
• Respiratory diseases (COPD, asthma, inflammation, chronic cough)
• Patients with elevated intracranial pressure
• Patients undergoing repeat surgery
• History of allergy to the investigational drug used in the study
• Patients with psychiatric disorders or alcohol abuse (daily ethanol intake ≥40 g, or having experienced alcohol withdrawal within the past 6 months, or unable to control alcohol consumption)

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

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Second Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07641673 · YX2026-095(F1)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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