Postoperative pain
Conditions
Interventions
0.66 mg group:Dexmedetomidine 0.66mg transdermal patch
1.06 mg group:Dexmedetomidine 10.6 mg transdermal patch
placebo group: placebo transdermal patch
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) 18 years old = age =65 years old, regardless of gender; 2) Body weight =50 kg for male subjects and =45 kg for female subjects with 18 ?BMI?30 3) ASA grade I-III; 4) patients scheduled for elective laparoscopic surgery under general anesthesia and expected to have mild to moderate postoperative pain, who could accept the prescribed surgical anesthesia and postoperative analgesia; 5) Understand the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail, understand the research procedure, and sign the informed consent form in person before the trial; 6) The subjects were able to communicate well with the investigators and complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1) those who are known to be allergic to investigational drugs, rescue drugs or similar drugs, protocol-defined intraoperative medication, and skin adhesives, or who have contraindications to the use of such drugs; 2) subjects with significant differences in skin color and skin condition, sunburn, open wound, scar tissue, tattoo at the site of medication (upper arm) affecting drug absorption; 3) History of myocardial infarction or unstable angina pectoris, history of severe cardiac arrhythmia such as atrioventricular block (degree II or above), cardiac insufficiency, history of ischemic stroke or transient ischemic attack, history of psychiatric system (such as schizophrenia, depression, etc.), cognitive impairment, and epilepsy Subjects with medical history, or with diseases that affect normal pain scores; 4) positive for hepatitis B surface antigen, hepatitis C (HCV) antibody, HIV antibody or syphilis test; 5) ALT and AST> 1.5 times the upper limit of normal; BUN and/or Urea> 1.5 times the upper limit of normal; Cr> The upper limit of normal, dialysis within 28 days before surgery; PT or APTT or TT> Upper limit of normal; Or patients whose blood pressure was poorly controlled by medical treatment (SBP> in sitting position; 160 mmHg or SBP< 90 mmHg), or blood oxygen saturation (monitored for no oxygen / 10 min after cessation of oxygen therapy)< 94%; 6) use of an adrenergic receptor agonist or antagonist within 7 days before using the investigational drug, use of sedatives and analgesics within 48 hours before using the investigational drug; 7) use of any drugs that inhibit or induce hepatic metabolism of the investigational drug (e.g., inductors-barbiturates, carbamazepine, phenytoin, glucocorticoids, or omeprazole; Inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 8) having a history of drug abuse or alcohol abuse within 1 year before using the investigational drug; Heavy drinking is defined as consuming more than 14 standard units of alcohol per week (1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); 9) patients with a history of psychotropic and narcotic drug abuse; 10) planning to undergo a surgical procedure other than the current trial during the study period; 11) enroll in any clinical trial and receive an intervention within 3 months before use of the investigational product; 12) pregnant or lactating women; Subjects of childbearing potential and their partners were unwilling to use contraception throughout the study period; Or those with a planned pregnancy within 3 months of the end of the study (male included) Subjects); 13) unable to complete the study for other reasons or considered by the investigator to be inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;breathe;Area under curve of pain intensity score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Change;Pharmacokinetics/pharmacodynamics; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed