digestive disease
Conditions
Interventions
Group 1:Cipofol
Group 2:Propofol
Sponsors
Civil Aviation General Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients planning to undergo combined gastrointestinal endoscopy (including biopsy) and combined gastrointestinal endoscopy with polypectomy. 2. Aged 65-80 years, ASA classification I-III. 3. The body mass index (BMI) is 18.5-30 kg/m^2 [BMI=weight (Kg)/height (m)^2] (2013 US Guidelines for the Management of Adult Overweight and Obesity). 4. The respiratory frequency during the screening and baseline periods should be >=10 and =95% when inhaling air; SBP>=110mmHg; DBP>=70mmHg; heart rate should be >=60 and <=100 breaths/min. 5. Be ethical, 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 who have contraindications to deep sedation/general anesthesia or have a history of sedation/anesthesia accidents in the past; 2. Those who are known to be allergic to eggs, soy products, opioids and their rescue drugs, medium and long-chain propofol, etc.; those who have contraindications to medium and long-chain propofol, opioids and their rescue drugs; 3. Before screening/baseline, there is the following medical history or evidence that increases the risk of sedation/anaesthesia: (1) Cardiovascular history: uncontrolled hypertension [without antihypertensive treatment with systolic blood pressure (SBP) >= 180mmHg and/or diastolic blood pressure (DBP) >= 110mmHg, or after treatment with antihypertensive drugs, SBP > 170mmHg and/or DBP > 105mmHg], severe arrhythmia, unstable angina, or myocardial infarction occurred within 3 months before the screening period; (2) History of respiratory system: history of respiratory insufficiency, obstructive lung disease; history of bronchospasm requiring treatment within 3 months before the screening period, acute respiratory infection within 1 week, and obvious fever, wheezing, those with nasal congestion and cough; (3) History of cerebrovascular disease: patients with brain injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; schizophrenia, mania, mental disorder, long-term use of psychotropic drugs, history of cognitive dysfunction, etc.; (4) History of gastrointestinal tract: gastrointestinal retention, active bleeding, possible reflux and aspiration, etc.; (5) Uncontrolled history of diseases that have significant clinical significance such as liver, kidney, blood system, nervous system, or metabolic system that the investigator judges may not be suitable for participating in the study; (6) There is a history of alcohol abuse in the 3 months before the screening period, which means that the average daily alcohol consumption is> 2 units of alcohol (1 unit = 360mL beer or 45mL 40% alcoholic liquor or 150mL wine); (7) There is a history of drug abuse within 3 months before the screening period; 4. Patients with the following respiratory management risks: history of asthma, wheezing; patients with sleep apnea syndrome; patients with a history of malignant high fever or family history; patients who have failed tracheal intubation; at the time of screening, the investigator judged that there was a difficult airway or was judged to be difficult to intubate the trachea (modified Markov score is level IV); 5. Those who have participated in any drug clinical research within 1 month before the screening period; have used medium and long-chain propofol, other sedatives/narcotics and/or opioid analgesics or compound preparations containing analgesics within 72 hours; 6. Screening/baseline laboratory examination indicators meet the following standards and re-check confirmed: neutrophil count = 1.5xULN; total bilirubin >= 1.5xULN; blood creatinine >= 1.2xULN. 7. Pregnant and lactating women; fertile women or men who are unwilling to use contraception during the entire study period; patients (including male patients) who have a pregnancy plan within 1 month after the study; 8. The researcher believes that there are any other patients who are not suitable to partic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the induction time;time away from the room; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure;heart rate;oxyhemoglobin saturation;frequency of respiratory depression;the injection pain;bispectral index;additional times of vasoactive drugs; | — |
Countries
China
Contacts
Public ContactWang Nan
Civil Aviation General Hospital
Outcome results
None listed