Quality of perioperative awakening
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, gender unlimited; 2. ASA grade is I-II; 3. 18 kg/m2 <= BMI <= 30kg/m2; 4. Subjects who plan to undergo bronchoscopic diagnosis and/or treatment with laryngeal mask ventilation; 5. Able to understand and voluntarily sign an informed consent form (ICF), willing to comply with and expected to complete the test according to the requirements of the test protocol.
Exclusion criteria
Exclusion criteria: 1. Persons with a contraindication to deep sedation/general anesthesia or a history of previous sedation/anesthesia accidents; 2. Those who are allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, lidocaine, and their drug components; 3. Those who have undergone tracheal intubation and/or mechanical ventilation prior to bronchoscopic consultation; 4. Those with combined severe cardiovascular, respiratory, or neurological diseases that are not well controlled; 5. Those whose laboratory tests are not indicative; 6. Those with a modified marsupial score of grade III or higher; 7. History of substance abuse, drug abuse, alcoholism, and long-term psychotropic drug use within 1 year prior to the start of the screening period. Alcohol abuse defined as regular alcohol consumption more than 14 times/week (1 time = 150 mL of wine or 360 mL of beer or 45 mL of spirits); 8. Pregnant or breastfeeding women; 9. Those who participated in any clinical trial (including drug or device clinical trials) as a subject within 1 month prior to enrollment; 10. Other conditions that are determined by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grading of anesthetic effects;awakening time;Steward score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions;Adverse reactions; | — |
Countries
China
Contacts
The First Affiliated Hospital of University of Science and Technology of China