Effects of Different Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy
8 сентября 2026 г. обновлено: Zhu Guoying, The Second People's Hospital of Huai'an
Effects of Different Preoperative Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy: A Randomized Controlled Trial
Patients undergoing thyroid surgery often experience significant preoperative anxiety and show high concern about voice changes, scar formation and other related issues.
Postoperative neck discomfort and dysphagia also tend to disrupt normal sleep.
Dexmedetomidine activates α₂ receptors in the mesencephalic-pontine-medullary reticular formation, inhibits the release of norepinephrine, and induces a sleep state similar to non-rapid eye movement (NREM) sleep, particularly the N2 stage, which is closer to physiological sleep.
This study aimed to explore the effects of intranasal spray versus intravenous administration of dexmedetomidine on postoperative sleep quality in patients undergoing thyroidectomy.
By optimizing preoperative pharmacological intervention, it intends to improve patients' postoperative sleep quality, relieve pain and reduce postoperative adverse reactions, enhance recovery quality, and optimize patients' satisfaction and comfort level.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
This randomized controlled trial was conducted to evaluate the effects of different administration routes of dexmedetomidine on postoperative sleep quality in patients undergoing thyroidectomy. A total of 120 patients were randomized into three groups in a 1:1:1 ratio using computer-generated randomization and sealed opaque envelopes.
Group A (intranasal DEX group): 100 μg dexmedetomidine was administered via intranasal spray 30 min before surgery (alternating sprays into bilateral nasal cavities), accompanied by intravenous infusion of an equal volume of normal saline. Group B (intravenous DEX group): Dexmedetomidine 0.5 μg/kg was intravenously infused 30 min before surgery with a 10 minute intravenous loading infusion, together with intranasal spray of an equal volume of normal saline. Group C (control group): An equal volume of normal saline was administered via both intranasal spray and intravenous route 30 min before surgery.
Patients, attending anesthesiologists, and outcome assessors were blinded to group allocation throughout the study. Intraoperative anesthesia management was performed by a separate anesthesiologist not involved in data assessment to maintain blinding. All patients received routine preoperative fasting and fluid deprivation. After entering the operating room, peripheral venous access was established and invasive arterial puncture was performed. Electrocardiography (ECG), pulse oxygen saturation (SpO₂), non invasive blood pressure (NIBP), invasive blood pressure (IBP), and bispectral index (BIS) were monitored.General anesthesia was induced with rocuronium 0.6 mg/kg, sufentanil 0.5 μg/kg, and propofol 1.5 mg/kg. Following induction, tracheal intubation was performed under video laryngoscopy, and the patient was connected to an anesthesia machine for mechanical ventilation. Ventilator settings: controlled ventilation with pure oxygen at 2.0 L/min, tidal volume 6-8 ml/kg, inspiratory-to-expiratory ratio 1:2, to maintain end-tidal carbon dioxide (PetCO₂) at 35-45 mmHg (1 mmHg = 0.133 kPa). During surgery, intravenous infusions of propofol (4-12 mg·kg-¹·h-¹) and remifentanil (0.2-0.4 μg·kg-¹·min-¹) were used to maintain appropriate depth of anesthesia (BIS maintained between 40 and 60). Vasopressor agents such as ephedrine and phenylephrine were administered according to intraoperative conditions. Immediately after the operation, patients were transferred to the post-anesthesia care unit (PACU). The tracheal tube was removed once consciousness and respiration recovered satisfactorily. Ketorolac tromethamine injection was administered for rescue analgesia when postoperative pain rescue was required.
Тип исследования
Интервенционный
Регистрация (Действительный)
120
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Huai'an, Китай
- The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital, Huaian
-
-
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:
- Aged 18-65 years;
- ASA physical status classification I-II;
- BMI ranging from 18 to 30 kg/m²;
- Scheduled for general anesthesia thyroidectomy for benign or malignant thyroid lesions;
- No history of sedative or hypnotic medication within one week before surgery.
Exclusion Criteria:
- History of sleep disturbance or psychiatric disorders;
- Use of antidepressants, hypnotics or other sleep affecting medications;
- Allergy to dexmedetomidine;
- Nasal lesions or intolerance to intranasal spray administration;
- Severe cardiac conduction block, bradycardia or hypotension;
- Pregnant or lactating patients;
- Complicated with severe dysfunction of heart, liver, brain, kidney or other organs;
- Difficult airway encountered during anesthesia induction requiring modification of routine intubation strategy.o need to change the conventional intubation method
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: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Dexmedetomidine Intravenous Group
Thirty minutes before surgery, dexmedetomidine 0.5 μg/kg is administered intravenously as a 10-minute loading dose, with an equal volume of 0.9% normal saline given via nasal spray simultaneously.
|
Thirty minutes before surgery, dexmedetomidine 0.5 μg/kg is administered intravenously as a 10-minute loading dose, with an equal volume of 0.9% normal saline given via nasal spray simultaneously.
Thirty minutes before surgery, 100 μg dexmedetomidine nasal spray was administered via alternating bilateral nostrils, with an equal volume of 0.9% normal saline pumped intravenously simultaneously.
|
|
Плацебо Компаратор: Control Group
An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.
|
An equal volume of 0.9% normal saline is administered via both nasal spray and intravenous route.
|
|
Экспериментальный: Dexmedetomidine Nasal Spray Group
Thirty minutes before surgery, 100 μg dexmedetomidine nasal spray was administered via alternating bilateral nostrils, with an equal volume of 0.9% normal saline pumped intravenously simultaneously.
|
Thirty minutes before surgery, dexmedetomidine 0.5 μg/kg is administered intravenously as a 10-minute loading dose, with an equal volume of 0.9% normal saline given via nasal spray simultaneously.
Thirty minutes before surgery, 100 μg dexmedetomidine nasal spray was administered via alternating bilateral nostrils, with an equal volume of 0.9% normal saline pumped intravenously simultaneously.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Richards-Campbell Sleep Questionnaire（RCSQ）
Временное ограничение: Postoperative day 0
|
This scale was developed by Richards et al.
It is a simple self-report scale specifically designed for ICU patients, widely used in sleep assessment research in critical care medicine and post-anesthesia fields.
The RCSQ includes 6 items: the first 5 are core scoring items, assessing sleep depth, difficulty in falling asleep, number of awakenings, ability to fall back asleep, and overall sleep quality respectively; the 6th is an environmental noise assessment item (not included in the total score, only for reference).
Each core item uses a 100 mm Visual Analog Scale (VAS): the left end is 0 points (worst state), the right end is 100 points (best state), and the score is the distance from the left end to the subject's marked position.
The total score is the arithmetic mean of the 5 core items (range 0-100 points), with higher scores indicating better sleep.
Clinical grading: <50 points (poor), 50-69 points (moderate), ≥70 points (good).
|
Postoperative day 0
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Visual Analog Scale（VAS）
Временное ограничение: 6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
|
The Visual Analog Scale (VAS) is a tool used to assess the intensity of subjective symptoms (such as pain, itching, anxiety, etc.).
Through a line of fixed length (usually 10 cm), patients mark the severity of their current symptoms based on their own feelings.
The scale is a horizontal straight line, with "no symptoms" (0 points) marked at one end and "the most severe symptoms" (10 points) at the other end.
Patients mark a position on the line that matches their symptoms, and the rater measures the distance from the starting point to the marked position, which is converted into a score ranging from 0 to 10 points.
A score of 0 means no symptoms at all (e.g., no pain), 1-3 points indicate mild symptoms (not affecting daily life), 4-6 points indicate moderate symptoms (affecting life but tolerable), and 7-10 points indicate severe symptoms (intolerable and requiring urgent intervention).
|
6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
|
|
Richmond Agitation and Sedation Scale(RASS)
Временное ограничение: 6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
|
The Richmond Agitation-Sedation Scale (RASS) is a widely used tool to assess the level of sedation and agitation in patients.
It ranges from +4 to -5, with specific descriptors for each score: +4 indicates combative behavior; +3 is extremely agitated; +2 means agitated and restless ; +1 denotes restless but calm; 0 represents alert and calm; -1 is drowsy; -2 indicates light sedation; -3 means moderate sedation; -4 is deep sedation ; and -5 represents unarousable.
This scale helps clinicians objectively evaluate and adjust sedation levels to ensure patient comfort and safety.
|
6 Hours Post-Operative, 12 Hours Post-Operative, 24 Hours Post-Operative, 48 Hours Post-Operative
|
|
Drug use
Временное ограничение: Perioperative
|
Record the intraoperative consumption of propofol and remifentanil, the names and dosages of intraoperative vasoactive drugs, and the postoperative consumption of rescue analgesics (including PACU).
|
Perioperative
|
|
Richards-Campbell Sleep Questionnaire（RCSQ）
Временное ограничение: Preoperative day 1，Postoperative day 1，Postoperative day 7
|
This scale was developed by Richards et al.
It is a simple self-report scale specifically designed for ICU patients, widely used in sleep assessment research in critical care medicine and post-anesthesia fields.
The RCSQ includes 6 items: the first 5 are core scoring items, assessing sleep depth, difficulty in falling asleep, number of awakenings, ability to fall back asleep, and overall sleep quality respectively; the 6th is an environmental noise assessment item (not included in the total score, only for reference).
Each core item uses a 100 mm Visual Analog Scale (VAS): the left end is 0 points (worst state), the right end is 100 points (best state), and the score is the distance from the left end to the subject's marked position.
The total score is the arithmetic mean of the 5 core items (range 0-100 points), with higher scores indicating better sleep.
Clinical grading: <50 points (poor), 50-69 points (moderate), ≥70 points (good).
|
Preoperative day 1，Postoperative day 1，Postoperative day 7
|
|
The sleep data recorded by the Fitbit Charge 6 bracelet
Временное ограничение: Preoperative day 1，Postoperative day 0，Postoperative day 1
|
The sleep data recorded by the Fitbit Charge 6 bracelet includes total sleep duration, wake time, deep sleep duration .
|
Preoperative day 1，Postoperative day 0，Postoperative day 1
|
|
The Quality of Recovery-15（QoR-15）
Временное ограничение: Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7
|
The QoR-15 scale is divided into five dimensions: physical comfort (5 items), self-care (2 items), psychological support (2 items), emotional state (4 items), and pain (2 items), with each item rated on a scale of 0-10, and the total score ranging from 0-150, with the higher the score the better the quality of recovery, and a score of 118 and above indicating surgery.
|
Preoperative day 1，Postoperative day 0，Postoperative day 1，Postoperative day 7
|
|
Hemodynamic indicators
Временное ограничение: on operating room admission (T0), immediately before intubation (T1), immediately after intubation (T2), at skin incision (T3), 30 min after surgical commencement (T4), at the end of surgery (T5), and immediately before extubation (T6).
|
The perioperative blood pressure, heart rate (HR) and mean arterial pressure (MAP) are important hemodynamic indicators for evaluating the patient's perioperative condition.
|
on operating room admission (T0), immediately before intubation (T1), immediately after intubation (T2), at skin incision (T3), 30 min after surgical commencement (T4), at the end of surgery (T5), and immediately before extubation (T6).
|
|
Time
Временное ограничение: Perioperative
|
emergence time, PACU stay duration and hospital length-of-stay were recorded.
|
Perioperative
|
|
Adverse Reaction
Временное ограничение: 48 Hours After Surgery
|
Record adverse reactions such as hypotension, bradycardia, nausea and vomiting, dizziness, hoarseness, postoperative hemorrhage, dysphagia, xerostomia, and nasal dryness.
|
48 Hours After Surgery
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Jun Wang, The Second People's Hospital of Huai'an
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- He J, Zhang X, Li C, Fu B, Huang Y, Li H. Dexmedetomidine nasal administration improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing general anesthesia. BMC Anesthesiol. 2024 Jan 30;24(1):42. doi: 10.1186/s12871-024-02417-9.
- Liu H, Wei H, Qian S, Liu J, Xu W, Luo X, Fang J, Liu Q, Cai F. Effects of dexmedetomidine on postoperative sleep quality: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Mar 21;23(1):88. doi: 10.1186/s12871-023-02048-6.
- Wang L, Liang XQ, Sun YX, Hua Z, Wang DX. Effect of perioperative dexmedetomidine on sleep quality in adult patients after noncardiac surgery: A systematic review and meta-analysis of randomized trials. PLoS One. 2024 Dec 5;19(12):e0314814. doi: 10.1371/journal.pone.0314814. eCollection 2024.
- Wu J, Liu X, Ye C, Hu J, Ma D, Wang E. Intranasal dexmedetomidine improves postoperative sleep quality in older patients with chronic insomnia: a randomized double-blind controlled trial. Front Pharmacol. 2023 Nov 16;14:1223746. doi: 10.3389/fphar.2023.1223746. eCollection 2023.
- Maras Baydogan G, Surme Y, Kutuk Karasungur S. The challenges experienced by patients in the early period after thyroidectomy and the effects on sleep quality. Support Care Cancer. 2025 May 1;33(5):438. doi: 10.1007/s00520-025-09483-w.
- Koo DL, Park Y, Nam H, Chai YJ. Sleep quality of patients with papillary thyroid carcinoma: a prospective longitudinal study with 5-year follow-up. Sci Rep. 2022 Nov 5;12(1):18823. doi: 10.1038/s41598-022-23549-3.
- Wang Y, Jin Z, Xu W, Chen K, Wei L, Yang D, Deng X, Tong S. Clinical observation of dexmedetomidine nasal spray in the treatment of sleep disorders on the first night after undergoing maxillofacial surgery: a single-center double-blind randomized controlled study. J Pharm Pharm Sci. 2023 Oct 3;26:11699. doi: 10.3389/jpps.2023.11699. eCollection 2023.
- Li X, Yan L, Wang L, Chen H, Yang B. Study on the preventive effect of dexmedetomidine on anesthetic associated sleep disturbance in young to middle-aged female patients undergoing hysteroscopy: a study protocol for a crossover randomized controlled trial. Trials. 2024 Jul 15;25(1):480. doi: 10.1186/s13063-024-08311-6.
- Yang WY, Huang K, Lin ZJ, Zeng W, Liu X, Liu HB, Zhong ML, Wei J, Liang WD, Wang LF, Chen L. Intranasal Dexmedetomidine for the Management of Preoperative Anxiety-Related Insomnia: A Randomized, Three-Blinded, Clinical Trial Compared with Lorazepam and Placebo. Drug Des Devel Ther. 2024 Dec 17;18:6061-6073. doi: 10.2147/DDDT.S487463. eCollection 2024.
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 (Действительный)
5 января 2026 г.
Первичное завершение (Действительный)
30 июня 2026 г.
Завершение исследования (Действительный)
30 июня 2026 г.
Даты регистрации исследования
Первый отправленный
13 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
27 мая 2026 г.
Первый опубликованный (Действительный)
3 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 0009-0001-3762-5246
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. .