lung desease
Conditions
Interventions
Group A:Innovative laryngeal mask for painless fiberoptic bronchoscope
Sponsors
Department of Anesthesiology, the First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years, regardless of gender; 2.ASA is classified as I-III; 3.18 kg/m^2= 93%; SBP >= 90mmHg DBP >= 55mmHg 50 beats /min <= heart rate <=100 beats/min; 6.Be able to understand and voluntarily sign the informed consent form (ICF), and be willing to abide by and expect to complete the test according to the requirements of the test plan.
Exclusion criteria
Exclusion criteria: 1.Those who have contraindications of deep sedation/general anesthesia or have had a history of sedation/anesthesia accidents in the past; 2.Allergic or taboo to benzodiazepines, opioids, propofol, Masini, naloxone, lidocaine and other drugs and their pharmaceutical components; 3.Those who have undergone endotracheal intubation and/or mechanical ventilation before bronchoscopy; 4.The screening period/baseline period has the following medical history: (1)History of cardiovascular system: 1)Uncontrolled or poorly controlled blood pressure [SBP >= 170 mmHg and/or DBP >= 105 mmHg without antihypertensive treatment, or SBP>160mmHg and/or DBP > 100 mmHg after antihypertensive treatment]; 2)Aneurysm; Heart failure (NYHA grade III-IV); Severe superior vena cava obstruction syndrome; Severe arrhythmia (such as third-degree atrioventricular block, Adams-stokes syndrome, etc.); Unstable angina pectoris; Myocardial infarction occurred within 6 months before screening; Heart rate of resting electrocardiogram = 1.5 x ULN; (4)The time of activating partial thromboplastin >= 1.5 x ULN; (5)Glutamic pyruvic transaminase and/or glutamic oxaloacetic transaminase >= 3 x ULN; (6)Total bilirubin >= 1.5 x ULN; (7)Serum creatinine >= 1.5 x ULN. 6.The modified Markov score is Grade III or above; 7.There is a history of drug abuse, drug abuse, alcoholism and long-term use of psychotropic drugs within 2 years before the start of the screening period. Alcoholism is defined as regular drinking more than 14 times a week (once = 150 mL wine or 360 mL Beer or 45 mL spirits); 8.Pregnant or lactating women; 9.Fertility women or men are unwilling to use contraception during the whole study period; Or subjects who have a pregnancy plan within 3 months after the end of the study (including male subjects); 10.Those who participated in any clinical trials (including clinical trials of drugs or devices) as subjects within 1 month before being selected; 11.Other circumstances judged by the researcher as unsuitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| minimum pulse oxygen saturation; | — |
Secondary
| Measure | Time frame |
|---|---|
| bronchoscope time;anesthesia recovery time;satisfaction of endoscope doctor;blood pressure;heart rate;pulse oxygen saturation; | — |
Countries
China
Contacts
Public ContactXia Min
Department of Anesthesiology, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Outcome results
None listed