It is suitable for all diseases examined by painless fiberoptic bronchoscopy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects scheduled for painless fiberoptic bronchoscopy under general anesthesia; 2. 18 years old <= age <=65 years old, regardless of gender;18 kg/m^2<= body mass index <=28 kg/m^2; 3. ASA grade I-III before operation; 4. Patients agreed to participate in the trial and signed a voluntary informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with known or suspected allergy or contraindication to study drug or other opioids; 2. Clinically significant abnormal liver and kidney function (ALT and AST > 1.5 times upper limit of normal;BUN and/or Urea > 1.5 times upper limit of normal;Cr > upper limit of normal;Dialysis within 28 days before surgery), or clinically significant coagulation dysfunction (PT or APTT or TT > upper limit of normal), or poorly controlled blood pressure (SBP in sitting position > 160mmHg or SBP =III), unstable angina pectoris or acute myocardial infarction in the past 6 months; 8. Patients with a history of neurological abnormalities, such as epilepsy or acute seizure; 9. Patients with chronic pain related to non-surgical sites (continuous use for 3 months or intermittent use for 6 months), or long-term use of analgesics (including opioids and NSAIDs) (continuous use for 4 weeks or more); 10. Patients with mental disorders (such as depression) or long-term use of psychotropic drugs (including sedatives, antidepressants, etc.); 11. Subjects with history of drug abuse, drug abuse or alcohol abuse in the previous 2 years were screened. Binge drinking was defined as regularly consuming alcohol more than 14 times/week (1 time ˜150 mL wine or 360 mL beer or 45 mL spirits); 12. Use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors (SNRIs), and serotonin-reuptake inhibitors (SSRIs) within two weeks before the first dose. 13. Pregnant or lactating women or subjects (including men) who plan to have children within 6 months; 14. Patients who participated in any clinical trial within 3 months before the first dose; 15. Other conditions deemed by the investigator to be ineligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory Depression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body movement;tracheal and bronchospasm;cough; | — |
Countries
China
Contacts
Zhejiang Provincial People's Hospital