Clinical trial NCT06849466: Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain
Official title: Effect of Perioperative Dexmedetomidine Sleep Promotion Management on Chronic Post-Surgical Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Post-Surgical Pain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
First posted: 2025-02-27
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI)
timeFrame: at 3 months after surgery
measure: the number of participants with CPSP.
timeFrame: at 3 months after surgery
Secondary outcomes:
measure: Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1, 3, and 6 months after surgery.
measure: Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)
timeFrame: 1st, 2nd, and 3rd days after surgery.
measure: Objective sleep assessment: Total sleep duration, wake - up time during sleep, and deep sleep time.
timeFrame: 1st, 2nd, and 3rd days after surgery
measure: Emotional state assessment: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1st, 2nd, and 3rd days after surgery
measure: Pain assessment: Numerical rating scale (NRS)
timeFrame: 1st, 2nd, 3rd days after surgery and at 1, 2, 3, 6 months after surgery
measure: Quality of recovery assessment: Quality of Recovery-15 (QoR-15) assessment scale
timeFrame: 1st and 3rd days after surgery
measure: Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36)
timeFrame: 1, 3, 6 months after surgery
measure: Incidence of chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI)
timeFrame: at 6 months after surgery
measure: the number of participants with CPSP.
timeFrame: at 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology, Peking Union Medical College Hospital
state: Beijing
Study officials:
References: