Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain

NCT ID: NCT06849466

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-06-30

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.

Conditions

Chronic Post-Surgical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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.

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

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: DRUG

The saline solution will be used as a placebo, and the same device will be employed for intranasal administration.

Interventions

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.

Intervention Type: DRUG

Saline solution

The saline solution will be used as a placebo, and the same device will be employed for intranasal administration.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

UNKNOWN

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lu Che

Attending Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40780715 (View on PubMed)

Other Identifiers

K7581

Identifier Type: -

Identifier Source: org_study_id