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Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Apr 1, 2025 to Jul 1, 2025 · Primary endpoints: 2 to 1 · Secondary endpoints: 9 to 8v3 Show 3 more changesShow less
    • Start date changed from estimate of Apr 1, 2025 to Jul 1, 2025
    • Primary endpoints: 2 to 1
    • Secondary endpoints: 9 to 8

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Start date: Mar 1, 2025 to Apr 1, 2025 Eligibility criteria shortened, about 6 wordsv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06849466
Lead Sponsor Peking Union Medical College Hospital
Collaborators: National Cancer Center, China
Conditions Chronic Post-Surgical Pain
Enrollment 364 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov