General anesthetics for painless bronchoscopy
Conditions
Interventions
Group 1:The researcher will dilute the test drug with saline to 40 mg/20ml
Group 2:Propofol
Sponsors
Shanghai Fourth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Subjects undergoing bronchoscopy diagnosis and/or treatment under general anesthesia with laryngeal mask; 2. Male or female, ASA grade I-III, age >= 18 and = 18 and = 10 and = 93% when inhaling air; SBP >= 90 mmHg; DBP >= 55 mmHg; heart rate should be >= 50 and <= 100 breaths/min; 5. Able to understand the procedures and methods of this research, willing to sign an informed consent form and strictly abide by the clinical research protocol to complete this research.
Exclusion criteria
Exclusion criteria: 1. Those with contraindications for deep sedation/general anesthesia or those with previous history of sedation/anesthesia accidents; 2. People who are known to be allergic to eggs, soy products, opioids and their rescue drugs, propofol, etc.; those with contraindications for propofol, opioids and their rescue drugs; 3. Patients who have undergone endotracheal intubation and/or mechanical ventilation before bronchoscopy; 4. Before screening/baseline period, there is the following medical history or evidence of increasing the risk of sedation/anesthesia: (1) Cardiovascular history: uncontrolled hypertension [systolic blood pressure (SBP) >= 170 mmHg and/or diastolic blood pressure (DBP) >= 105 mmHg without antihypertensive drug treatment, or SBP > 160 mmHg and/or after antihypertensive drug treatment DBP > 100 mmHg], aneurysm, severe arrhythmia, heart failure, Adams-Stokes syndrome, New York Heart Association (NYHA) functional class >= III, severe superior vena cava obstruction syndrome, pericardium effusion, acute myocardial ischemia, unstable angina, myocardial infarction within the past 6 months before screening, history of tachycardia/bradycardia requiring drug therapy, II-III degree atrioventricular block (excluding use of pacing organ patients) or QTcF interval >= 450 ms [limited to the screening period (corrected by Fridericia's formula 1)]; (2) Respiratory system medical history: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat tumor, (bronchial) tracheoesophageal fistula or airway tear history, occurred within the past 2 weeks before screening severe respiratory infection; (3) Nervous and psychiatric medical history: craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident; schizophrenia, mania, insanity, long-term use of psychotropic drugs, cognitive History of dysfunction, etc.; (4) Gastrointestinal medical history: gastrointestinal retention, active bleeding, history of gastroesophageal reflux or obstruction, etc. may lead to reflux and aspiration; (5) Uncontrolled history of liver, kidney, blood system, nervous system or metabolic system with significant clinical significance and other diseases that the researchers judge may not be suitable for participating in the study; (6) There is a history of alcoholism within 3 months before the screening period. Alcoholism means that the average daily alcohol consumption is > 2 units of alcohol (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine); (7) History of drug abuse within 3 months before the screening period; (8) History of blood transfusion within 14 days before the screening period; 5. The screening period/baseline period has the following respiratory management risks: (1) Acute attack of asthma; (2) People with sleep apnea syndrome; (3) Have a history of malignant hyperthermia or family history; (4) Those who have failed tracheal intubation experience; (5) Difficult airway is judged by the researcher (such as: Modified Matheson Scale >= Grade III); 6. Any of the following drugs or treatments were used during the screening period/baseline period: (1) Participated in any drug clinical research within 1 month before screening; (2) Those who have used propofol, other sedative/anesthetic drugs and/or opioid analgesics or compound preparations containing analgesic ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure;Heart rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Injection pain;Cough; | — |
Countries
China
Contacts
Public ContactFang Chen
Shanghai Fourth People's Hospital
Outcome results
None listed