Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain

NCT06849466 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: K7581
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI) and Douleur Neuropathique 4 Questions (DN4）

  Phone interviews were conducted at 3 months after surgery by trained pain physicians following a standardized protocol at each participating centre. Primarily, the question was asked: "Do you currently have persisting pain related to your thoracoscopic surgery ?" If the answer is "YES", the BPI and DN-4 (Douleur Neuropathique4 questions, as Neuropathic pain four questions in English) were applied for pain evaluation. After that, CPSP will be finally diagnosed focusing on key diagnostic criteria including: (1) Pain arises or intensifies following surgery; (2) Pain persists for at least three months and impacts quality of life; (3) Pain occurs after a pain-free interval or evolves from ongoing acute postoperative pain; (4) Pain is localized to the surgical site or radiates to areas corresponding to the relevant nerve distribution; and (5) Other potential causes of pain have been excluded.

  at 3 months after surgery

Secondary Outcomes (8)

• Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)

  1, 3, and 6 months after surgery.

• Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)

  1st, 2nd, and 3rd days after surgery.

• Objective sleep assessment: Total sleep duration, wake - up time during sleep, and deep sleep time.

  1st, 2nd, and 3rd days after surgery

• Emotional state assessment: Hospital Anxiety and Depression Scale (HADS)

  1st, 2nd, and 3rd days after surgery

• Pain assessment: Numerical rating scale (NRS)

  1st, 2nd, 3rd days after surgery and at 1, 2, 3, 6 months after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

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

Drug: Saline solution

Interventions

Dexmedetomidine 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.

Dexmedetomidine group

Saline solution DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80 years,
• Elective surgical patients scheduled for their first thoracoscopic lung resectiony,
• ASA physical status I-III
• sign the informed consent form

You may not qualify if:

• Severe heart failure or left ventricular ejection fraction (LVEF) \<30%, or the presence of coronary artery disease, cardiac conduction abnormalities, or arrhythmias;
• Abnormal liver function, defined as ALT \>100 IU/L or Child-Pugh Class B;
• Renal insufficiency, characterized by an estimated glomerular filtration rate (eGFR) \<60 mL/min or a preoperative serum creatinine level \>120 µmol/L;
• A history of peptic ulcer disease, gastrointestinal bleeding, asthma, or cerebrovascular disease;
• Known allergy to medications potentially used in this study, including dexmedetomidine, propofol, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or local anesthetics;
• Body mass index (BMI) \>30 kg/m²;
• Preoperatively diagnosed psychiatric disorders, such as anxiety, depression, or sleep disturbances;
• Long-term use of opioids or sedatives, defined as usage for 3 months or longer;
• Pregnant women, postpartum individuals, and breastfeeding mothers;
• Patients anticipated to require postoperative admission to the intensive care unit (ICU);
• Patients with nasal abnormalities or conditions that preclude or contraindicate intranasal drug administration.

Sponsors & Collaborators

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

Study Sites (1)

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 40780715 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: For data access, interested parties should submit a formal request to the corresponding author of this study via pumchshenle@163.com. The request must contain a detailed data usage plan, a rational justification, and clear objectives for data utilization. All data requests are subject to review by the Peking Union Medical College Hospital Institutional Review Board. Only after ethical and legal assessments confirm compliance with relevant regulations and ensure no potential risks to study participants will the data be provided to the applicants.Moreover, supplementary information such as the study protocol or statistical analysis plan can be made available concurrently upon approval of the reasonable data request. The data are only permitted for use within the boundaries of ethical and legal permissions. Secondary dissemination or utilization for other research purposes without prior written authorization is strictly prohibited.

Locations

CN (1)