Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain

Официальное название

Effect of Perioperative Dexmedetomidine Sleep Promotion Management on Chronic Post-Surgical Pain: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if intranasal dexmedetomidine works to improve sleep quality to treat chronic post-surgical pain (CPSP) in patients undergoing thoracic surgery. It will also learn about the safety of intranasal dexmedetomidine.this clinical trial could include any of the following: Adults aged 18-80 years, Elective surgical patients scheduled for their first thoracoscopic lung resectiony, ASA physical status I-III, and sign the informed consent form. The main questions it aims to answer are: Does intranasal dexmedetomidine reduce the incidence of CPSP in patients undergoing elective thoracic surgery? Does perioperative sleep quality mediates the effect of intranasal dexmedetomidine in improving CPSP outcomes at 3 months post-surgery? What are the safety concerns or medical complications that participants may experience when using intranasal dexmedetomidine perioperatively? Researchers will compare the intervention group receiving intranasal dexmedetomidine to a placebo (a look-alike substance that contains no drug) to assess its impact on perioperative sleep quality and the reduction in CPSP incidence at 3 months post-surgery. Participants will: Take the study drug (intranasal dexmedetomidine) or a placebo (saline) every night between 9:00-9:30 PM, starting the day before surgery and continuing until the day before discharge. After the drug administration, undergo 3 hours of continuous monitoring with ECG and wear a wearable device for ongoing assessment. Cooperate with researchers to assess sedation, pain, sleep, emotional status, medication usage, adverse events, and postoperative recovery quality on postoperative days 1, 2, and 3 You will be contacted by phone at 1, 3, and 6 months by the research team to inquire about sleep, pain, medication use, and overall quality of life after discharge.

Вмешательства

• Препарат Dexmedetomidine
  Dexmedetomidine Hydrochloride Nasal Spray Dexmedetomidine is a selective alpha-2 adrenergic agonist primarily used for its sedative, anxiolytic, and analgesic effects. It works by inhibiting the release of norepinephrine in the central nervous system, leading to sedation, decreased anxiety, and reduced pain sensitivity. When used intranasally, it can offer an effective, non-invasive method for sedating patients and improving sleep quality, particularly in perioperative settings.
• Препарат Saline solution
  The saline solution will be used as a placebo, and the same device will be employed for intranasal administration.

Первичные конечные точки

• Incidence of chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI) and Douleur Neuropathique 4 Questions (DN4） [Срок оценки: at 3 months after surgery]

Вторичные конечные точки (8)

• Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 1, 3, and 6 months after surgery.]
• Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ) [Срок оценки: 1st, 2nd, and 3rd days after surgery.]
• Objective sleep assessment: Total sleep duration, wake - up time during sleep, and deep sleep time. [Срок оценки: 1st, 2nd, and 3rd days after surgery]
• Emotional state assessment: Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 1st, 2nd, and 3rd days after surgery]
• Pain assessment: Numerical rating scale (NRS) [Срок оценки: 1st, 2nd, 3rd days after surgery and at 1, 2, 3, 6 months after surgery]
• Quality of recovery assessment: Quality of Recovery-15 (QoR-15) assessment scale [Срок оценки: 1st and 3rd days after surgery]
• Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36) [Срок оценки: 1, 3, 6 months after surgery]
• Incidence of chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI) and Douleur Neuropathique 4 Questions (DN4) [Срок оценки: at 6 months after surgery]

Критерии участия

Критерии включения

• Adults aged 18-80 years,
• Elective surgical patients scheduled for their first thoracoscopic lung resectiony,
• ASA physical status I-III
• sign the informed consent form

Критерии исключения

• Severe heart failure or left ventricular ejection fraction (LVEF) <30%, or the presence of coronary artery disease, cardiac conduction abnormalities, or arrhythmias;
• Abnormal liver function, defined as ALT >100 IU/L or Child-Pugh Class B;
• Renal insufficiency, characterized by an estimated glomerular filtration rate (eGFR) <60 mL/min or a preoperative serum creatinine level >120 µmol/L;
• A history of peptic ulcer disease, gastrointestinal bleeding, asthma, or cerebrovascular disease;
• Known allergy to medications potentially used in this study, including dexmedetomidine, propofol, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or local anesthetics;
• Body mass index (BMI) >30 kg/m²;
• Preoperatively diagnosed psychiatric disorders, such as anxiety, depression, or sleep disturbances;
• Long-term use of opioids or sedatives, defined as usage for 3 months or longer;
• Pregnant women, postpartum individuals, and breastfeeding mothers;
• Patients anticipated to require postoperative admission to the intensive care unit (ICU);
• Patients with nasal abnormalities or conditions that preclude or contraindicate intranasal drug administration.

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

• Department of Anesthesiology, Peking Union Medical College Hospital — Пекин

Публикации

• Xu L, Zhang Y, Che L, Shen L. Perioperative intranasal dexmedetomidine for the prevention of chronic postsurgical pain following thoracoscopic surgery: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Aug 8;15(8):e105832. doi: 10.1136/bmjopen-2025-105832. PMID 40780715

Идентификаторы

NCT: NCT06849466 · K7581

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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