Effect of Perioperative Dexmedetomidine Sleep Promotion Management on Chronic Post-Surgical Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Incidence of chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI) and Douleur Neuropathique 4 Questions (DN4）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Dexmedetomidine group
Patients in the dexmedetomidine group will receive intranasal dexmedetomidine from 1 day before surgery until 1 day prior to discharge. After being instructed on the usage method by the research team, patients will be guided to self-administer the dexmedetomidine nasal spray between 21:00 and 21:30.
The dosage will be based on body weight and will be as follows:
For patients weighing 40-49 kg: 2 sprays (50 µg) For patients weighing 50-69 kg: 3 sprays (75 µg) For patients weighing 70-89 kg: 4 sprays (100 µg) For patients weighing 90-100 kg: 5 sprays (125 µg) After administration, patients will be instructed to lie flat and prepare for sleep. Objective sleep quality will be monitored using wearable sleep monitoring devices.
干预措施: Dexmedetomidine (Drug)
Control group
Patients in the control group will receive intranasal placebo from 1 day before surgery until 1 day prior to discharge. After being instructed on the usage method by the research team, patients will be guided to self-administer an equal volume of spray between 21:00 and 21:30. Patients will be instructed to use the spray while in a semi-recumbent position, with saline solution administered based on the corresponding dosage:
For patients weighing 40-49 kg: 2 sprays For patients weighing 50-69 kg: 3 sprays For patients weighing 70-89 kg: 4 sprays For patients weighing 90-100 kg: 5 sprays After administration, patients will be instructed to lie flat and prepare for sleep. Objective sleep quality will be monitored using wearable sleep monitoring devices
干预措施: Saline solution (Drug)
结局指标
主要结局
Incidence of chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI) and Douleur Neuropathique 4 Questions (DN4）
时间窗: at 3 months after surgery
Phone interviews were conducted at 3 months after surgery by trained pain physicians following a standardized protocol at each participating centre. Primarily, the question was asked: "Do you currently have persisting pain related to your thoracoscopic surgery ?" If the answer is "YES", the BPI and DN-4 (Douleur Neuropathique4 questions, as Neuropathic pain four questions in English) were applied for pain evaluation. After that, CPSP will be finally diagnosed focusing on key diagnostic criteria including: (1) Pain arises or intensifies following surgery; (2) Pain persists for at least three months and impacts quality of life; (3) Pain occurs after a pain-free interval or evolves from ongoing acute postoperative pain; (4) Pain is localized to the surgical site or radiates to areas corresponding to the relevant nerve distribution; and (5) Other potential causes of pain have been excluded.
次要结局
- Emotional state assessment: Hospital Anxiety and Depression Scale (HADS)(1st, 2nd, and 3rd days after surgery)
- Pain assessment: Numerical rating scale (NRS)(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(1st and 3rd days after surgery)
- Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)(1, 3, and 6 months after surgery.)
- Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)(1st, 2nd, and 3rd days after surgery.)
- Objective sleep assessment: Total sleep duration, wake - up time during sleep, and deep sleep time.(1st, 2nd, and 3rd days after surgery)
- Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36)(1, 3, 6 months after surgery)
- Incidence of chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI) and Douleur Neuropathique 4 Questions (DN4)(at 6 months after surgery)
研究者
Lu Che
Attending Anesthesiologist
Peking Union Medical College Hospital