Patients scheduled for closed thoracostomy, including but not limited to those undergoing pleural effusion drainage or diagnostic thoracentesis
Conditions
Interventions
Placebo group:Placebo nasal spray (same volume, 4 sprays), administered intranasally 20 minutes before local anesthesia.
Intervention group:Dexmedetomidine Hydrochloride Nasal Spray, 100 µg (4 sprays), administered intranasally 20 minutes before local anesthesia.
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–65 years, regardless of gender; 2.Inpatients scheduled to undergo closed thoracic drainage surgery or those hospitalized after the surgery. 3.Voluntarily sign a written informed consent form. 4.Patients with stable vital signs, including heart rate, blood pressure, respiratory rate and oxygen saturation.
Exclusion criteria
Exclusion criteria: 1. Heart rate or pulse <60 beats/min during screening, or presence of clinically significant cardiac dysfunction as determined by the investigator, or history of severe arrhythmias such as second-degree or higher atrioventricular block, or heart failure (excluding patients with pacemakers); 2. Pregnant women or lactating mothers; patients with plans to conceive between 30 days before screening and 6 months after the trial completion, or who are unwilling or unable to use effective contraception; 3. Patients with a history of long-term use of sedative-hypnotic drugs, or a history of abuse of psychotropic or anesthetic drugs; 4. Patients allergic to any component of dexmedetomidine hydrochloride nasal spray or its excipients; 5. Patients with clinically significant nasal history, surgery history, or allergy history as judged by the investigator, which severely affects drug absorption (e.g., chronic nasal congestion, rhinorrhea, epistaxis, or abnormal nasal cavity structure or mucosa impairing drug absorption); 6. Patients with airway hyperreactivity, such as those with chronic obstructive pulmonary disease, asthma, or sleep apnea syndrome, as determined by the investigator to pose a safety risk; 7. Patients currently in coma, with impaired consciousness, or with psychiatric disorders (e.g., schizophrenia, depression) or cognitive impairment; or patients with a history of epilepsy; 8. History of myocardial infarction or unstable angina within 6 months prior to screening; 9. Arterial oxygen saturation (SpO2) =92% during screening under non-oxygenated conditions; 10. Patients with previous severe hypertension and poor blood pressure control; 11. Patients who participated in another clinical trial and received an investigational drug within 3 months prior to screening; 12. Patients who have used alpha-agonists within 12 hours prior to study drug administration; 13. Any other condition deemed by the investigator to render the patient unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of sedation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety Scores (HAMA and STAI-S-6);Sleep Score (RCSQ);Pain NRS Score;Patient Comfort Score for the Procedure;Physician Satisfaction Score for Patient Cooperation During the Procedure;Duration of Thoracic Closed Drainage Procedure; | — |
Countries
China
Contacts
Public ContactHu Jian
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed