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The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery

3 июня 2026 г. обновлено: Yun Wu, The Second Hospital of Anhui Medical University

The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Open Thyroid Surgery: A Randomized Controlled Study

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

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

136

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Yun Wu
  • Номер телефона: 8613865958254
  • Электронная почта: wuyunanyi@163.com

Места учебы

  • Китай
    • Anhui
      • Hefei, Anhui, Китай
        • Second Affiliated hospital of Anhui Medical University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • Patients scheduled for elective open thyroid surgery
  • ASA class I-II
  • Voluntarily participate in the study and sign the informed consent form

Exclusion Criteria:

  • 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)

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: ESK iv group
After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.
Лекарство: Esketamine
After anesthesia induction, continue to administer esketamine by infusion at 0.1 mg/kg/h during the maintenance phase of anesthesia, and stop the infusion of esketamine during suturing.
Плацебо Компаратор: CON group
After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;
Лекарство: Normal Saline
After anesthetic induction, an equal amount of saline is continuously infused by pump during the maintenance phase of anesthesia, and the saline infusion is stopped during suturing;

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Incidence of coughing during tracheal extubation
Временное ограничение: perioperative (From the awakening period to immediately after tracheal extubation)
2 point scales; 0=None; 0 = Did not occur; 1 = Occurred;
perioperative (From the awakening period to immediately after tracheal extubation)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Severity of coughing during tracheal extubation
Временное ограничение: perioperative (From the awakening period to immediately after tracheal extubation)
4 grade scales; Grade 0: No choking cough; Grade 1: Single cough episode, considered mild choking cough; Grade 2: Intermittent cough, lasting less than 5 seconds, considered moderate choking cough; Grade 3: Continuous severe cough, lasting more than 5 seconds, considered severe choking cough. The higher the degree, the worse it is.
perioperative (From the awakening period to immediately after tracheal extubation)
Agitation score during tube removal
Временное ограничение: perioperative (From the awakening period to immediately after tracheal extubation)
3-level scale; 1: Awake and calm; 2: Mild agitation but can be comforted; 3: Moderate agitation, difficult to comfort; 4: Severe agitation, cannot be comforted; The higher the degree, the worse the situation.
perioperative (From the awakening period to immediately after tracheal extubation)
Blood pressure
Временное ограничение: From the induction period until 5 minutes after the completion of surgery
Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
From the induction period until 5 minutes after the completion of surgery
Airway pressure 5 minutes after intubation and at the end of surgery
Временное ограничение: 5 minutes after intubation and at the end of the surgery
5 minutes after intubation and at the end of the surgery
Intraoperative use rate and dosage of vasoactive drugs
Временное ограничение: intraoperative (From the induction period to the end of anesthesia)
intraoperative (From the induction period to the end of anesthesia)
Sore throat score
Временное ограничение: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
4-point scales; 0 = None; 1 = Mild, milder than a common cold; 2 = Moderate, like a sore throat from a common cold; 3 = Severe, more severe than a common cold; The higher the score, the greater the level of pain.
Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
Hoarseness scores
Временное ограничение: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
4-point scores; 0 = None; 1 = Transient hoarseness occurs; 2 = Patient perceives hoarseness during visit; 3 = Hoarseness is clearly noticeable; The higher the score, the more severe the hoarseness.
Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively
Surgical area pain scores
Временное ограничение: Postoperative day 1 and day 2
Pain NRS scale score: 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain. The higher the score, the more severe the pain.
Postoperative day 1 and day 2
Incidence of adverse reactions within 48 hours postoperatively
Временное ограничение: Within day 2 after surgery
Within day 2 after surgery
Postoperative nausea and vomiting(PONV) score
Временное ограничение: Within day 2 after surgery

Vomiting: 0 = None; 1 = Once; 2 = Twice; 3 = Three times or more

Nausea, does it affect daily life: 0 = None; 1 = Sometimes; 2 = Often; 3 = Always
Within day 2 after surgery
Postoperative analgesic dosage
Временное ограничение: Within day 2 after surgery
Within day 2 after surgery
Postoperative time to first food
Временное ограничение: perioperative (Time from returning to the ward to the first food)
perioperative (Time from returning to the ward to the first food)
Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
Временное ограничение: Three month after surgery

Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms

  1. Vocal fatigue
  2. Difficulty speaking loudly
  3. Roughness
  4. Voice in low pitch
  5. Can"t speak in high pitch

  6. Voice in high pitch

    Swallowing/pharyngeal symptoms

  7. Burning during swallowing
  8. Pharyngeal bolus
  9. Pain during deglutition
  10. Pharyngeal pain
  11. Choking
  12. Dry throat
  13. Discomfort during swallowing
  14. Throat clearing
  15. Neck scar retraction during deglutition
  16. Foreign body sensation in pharynx
  17. Strangling sensation during swallowing
  18. Coughing during swallowing
  19. Foreign body in pharynx; The higher the score, the more severe it is.
Three month after surgery
Heart rate
Временное ограничение: Time Frame: From the induction period until 5 minutes after the completion of surgery
Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
Time Frame: From the induction period until 5 minutes after the completion of surgery
Oxygen saturation
Временное ограничение: Time Frame: From the induction period until 5 minutes after the completion of surgery
Baseline, post-induction, 1 minute after intubation, during suturing, at the end of surgery, 1 minute after extubation, 5 minutes after extubation
Time Frame: From the induction period until 5 minutes after the completion of surgery
Anesthesia time
Временное ограничение: perioperative (Time from induction to discontinuation of anesthetic agents)
perioperative (Time from induction to discontinuation of anesthetic agents)
Surgery time
Временное ограничение: From the start of surgery to the end of surgery
From the start of surgery to the end of surgery
Extubation time
Временное ограничение: perioperative (The time from discontinuation of anesthetic drugs to extubation)
perioperative (The time from discontinuation of anesthetic drugs to extubation)
Duration of tracheal tube placement
Временное ограничение: perioperative (Time from intubation to )
perioperative (Time from intubation to )
Awakening time
Временное ограничение: perioperative (Stop the anesthesia drug injection until awakening time)
perioperative (Stop the anesthesia drug injection until awakening time)
Post-anesthesia care unit (PACU) stay time
Временное ограничение: perioperative (Duration from entering the PACU to leaving the PACU)
perioperative (Duration from entering the PACU to leaving the PACU)
PACU RASS score
Временное ограничение: perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)
  • 4: Combative
  • 3: Very agitated
  • 2: Agitated

  • 1: Restless 0: Alert and calm

    • 1: Drowsy
    • 2: Light sedation
    • 3: Moderate sedation
    • 4: Deep sedation
    • 5: Unarousable
perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room.)
Intraoperative doses of propofol
Временное ограничение: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of remifentanil
Временное ограничение: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
Временное ограничение: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of sufentanil
Временное ограничение: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative fluid volume
Временное ограничение: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Intraoperative blood loss
Временное ограничение: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative (From the induction period to the end of anesthesia)
Sleep scores
Временное ограничение: Postoperative 24 hours and 48 hours
4 point scores; 1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep.
Postoperative 24 hours and 48 hours
Antiemetic drug dosage
Временное ограничение: Within day 2 after surgery
Within day 2 after surgery
Postoperative time to ambulation
Временное ограничение: Perioperative (From the operating room to discharge)
Perioperative (From the operating room to discharge)
Length of postoperative hospital stay
Временное ограничение: Perioperative (From the operating room to discharge)
Perioperative (From the operating room to discharge)
Postoperative time to first water intake
Временное ограничение: Perioperative (Time from returning to the ward to the first drink of water)
Perioperative (Time from returning to the ward to the first drink of water)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

The Second Hospital of Anhui Medical University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июня 2026 г.

Первичное завершение (Оцененный)

1 мая 2027 г.

Завершение исследования (Оцененный)

1 сентября 2027 г.

Даты регистрации исследования

Первый отправленный

20 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

3 июня 2026 г.

Первый опубликованный (Действительный)

4 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 июня 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • YX2026-124

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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