Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Invitation-only; Phase 4

Conditions: Chronic Post-Surgical Pain

Treatments: Drug: Dexmedetomidine; Drug: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06849466

K7581

Details and patient eligibility

About

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.

Enrollment: 364 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline solution