Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain
Enrolling by invitationPhase 4NCT06849466
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of Perioperative Dexmedetomidine Sleep Promotion Management on Chronic Post-Surgical Pain: A Randomized Controlled Trial
- Conditions
- Interventions
- Drug: Dexmedetomidine
- Drug: Saline solution
- Sponsor
- Peking Union Medical College Hospital
- Collaborators
- National Cancer Center, China
- Start date
- 2025-07-01
- Primary completion
- 2027-06-30
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06849466