None
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Scheduled for elective painless flexible bronchoscopy 2. Aged 18 to 65 years 3. Body mass index (BMI) 18–30 kg/m² 4. American Society of Anesthesiologists (ASA) physical status I–III 5. Serum alkaline phosphatase within the normal reference range (males: 45–125 U/L; females: 35–100 U/L) 6. Capable of understanding the study procedures and providing written informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindications to general anesthesia, including allergy to all anesthetic agents or a family history of malignant hyperthermia; 2. Severe cardiovascular disease, defined as unstable angina, acute or recent myocardial infarction (within 6 months), uncontrolled hypertension (systolic blood pressure [SBP] >=170 mmHg and/or diastolic blood pressure [DBP] >=105 mmHg on antihypertensive therapy, or SBP >160 mmHg and/or DBP >100 mmHg without therapy), SBP 120 beats/min), sick sinus syndrome, Adams–Stokes syndrome, Wolff–Parkinson–White syndrome, or prolonged QTc interval (males >=470 ms; females >=480 ms by Fridericia correction); 3. Severe pulmonary dysfunction, including acute exacerbation of severe chronic obstructive pulmonary disease, uncontrolled asthma, respiratory failure, severe airway stenosis, obstructive sleep apnea, or a history of difficult intubation or anticipated difficult airway; 4. Neurological or psychiatric conditions, including traumatic brain injury, elevated intracranial pressure, intracranial aneurysm, prior cerebrovascular accident, schizophrenia, mania, chronic psychotropic medication use, epilepsy, Parkinson disease, intracranial malignancy, or cognitive impairment precluding communication; 5. Known allergy to study medications or structurally related agents, or allergy to eggs, soybeans, or their derivatives; 6. History of substance or alcohol abuse within the preceding 3 months; 7. Pregnancy, lactation, or planned conception within 3 months; 8. Use of propofol or other sedatives or opioid analgesics within 72 hours before baseline data collection; 9. Uncontrolled diabetes mellitus (fasting glucose >10.0 mmol/L); 10. Severe hepatic or renal impairment (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >=3 times the upper limit of normal; total bilirubin >=1.5 times the upper limit of normal; serum creatinine >=1.5 times the upper limit of normal); 11. Participation in another clinical drug trial within the preceding month; 12. Current endotracheal intubation or mechanical ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the absolute area under the curve (AUC) of MAP deviation from baseline over the first 15 minutes following the start of anesthesia induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of intraoperative hypotension;nadir blood pressure values;incidence of intraoperative hypertension ;peak blood pressure values during the observation period;incidence of bradycardia;minimum and maximum BIS values during the observation period; proportion of time with BIS maintained within the 40–60 range;vasoactive drug consumption; total study drug and remifentanil dosages administered; frequency of study drug and remifentanil supplementation;induction time ; postoperative recovery indicators;incidence of intraoperative awareness;adverse reactions during the observation period;patient satisfaction; | — |
Countries
China
Contacts
Public ContactChan Chen
West China Hospital of Sichuan University
Outcome results
None listed