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ENROLLING BY INVITATION
NCT06849466
PHASE4

Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Perioperative Dexmedetomidine Sleep Promotion Management on Chronic Post-Surgical Pain: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

364

Start Date

2025-07-01

Completion Date

2027-06-30

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Saline solution

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

Locations (1)

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China