Sedated Bronchoscopy in ASA Class III Patients
Conditions
Interventions
Control group:Induction with intravenous bolus of propofol 2.0 mg/kg and alfentanil 8 µg/kg, followed by maintenance with continuous infusion pump of propofol at 1.5 mg/kg/h during the procedure.
Experimental group 1:Preoperative intravenous infusion of dexmedetomidine 0.75 µg/kg over 10 minutes followed by an alfentanil 8 µg/kg bolus for induction, with intraoperative maintenance via continuo
Experimental group 2:Preoperative intravenous infusion of dexmedetomidine 1.0 µg/kg over 10 minutes followed by an alfentanil 8 µg/kg bolus for induction, with intraoperative maintenance via continuou
Sponsors
Gansu Provincial Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Age>=40 years; 2)ASA Class III physical status; 3)Patients electing to undergo bronchoscopy under intravenous sedation; 4)Vital signs within protocol-defined ranges, with no contraindications to sedation/general anesthesia; 5)Patients providing written informed consent after clear understanding of the study
Exclusion criteria
Exclusion criteria: 1)Anticipated difficult airway(Mouth opening limitation, restricted neck/chin/jaw movement, ankylosing spondylitis, temporomandibular arthritis, partial tracheal stenosis, modified Mallampati class > III);2)History of hypoxemia(SpO2 < 90% with 2 L/min oxygen via nasal cannula);3)Known allergy or contraindications to opioids, dexmedetomidine, benzodiazepines, or their components(e.g., soy/egg products);4)Contraindications to routine bronchoscopy Including:;Severe hepatic/renal dysfunction;Coagulopathy;Full stomach or gastrointestinal obstruction with gastric content retention;Conditions precluding hypercapnia tolerance(Pulmonary hypertension, space-occupying neurological lesions);5)Poorly controlled life-threatening respiratory disorders(e.g., multiple bullae, acute asthma exacerbation, active massive hemoptysis);6)Poorly controlled life-threatening cardiovascular disorders(e.g., acute coronary syndrome, severe arrhythmia, decompensated heart failure, recent myocardial infarction (<6 months), severe superior vena cava syndrome);7)Severe neurological comorbidities(e.g., stroke, hemiplegia, seizures, epilepsy);8)Use of dexmedetomidine, other sedatives/anesthetics, and/or opioid analgesics within 1 week prior to dosing;9)Participation in other drug clinical trials within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchoscopic Procedure Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lowest Peripheral Oxygen Saturation (SpO2Nadir);Peripheral Oxygen Saturation (SpO2), Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR);Incidence of Injection Pain;Incidence of Respiratory Adverse Events;Incidence of Cardiovascular Adverse Events;Induction time,Procedure time,Time to fully alert,Time to leaving the recovery room;Patient Satisfaction,Operator Satisfaction,Anesthesiologist Satisfaction;Rescue Sedation Dose;Willing to the repeat FB;Quality of Recovery (QoR);Independent Assessment;Consumption of propofol,Consumption of dexmedetomidine,Consumption of alfentanil,Consumption of lidocaine jelly;Scores of bronchoscopy feasibility; | — |
Countries
China
Contacts
Public ContactWenjun Yan
Gansu Provincial Hospital
Outcome results
None listed