Biliary obstruction
Conditions
Interventions
Experimental group:Propofol intravenous anesthesia
control group:Ciprofol intravenous anesthesia
Sponsors
The General Hospital of the Northern Theater of the Chinese People's Liberation Army
Eligibility
Sex/Gender
Male
Age
65 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients undergoing elective ERCP surgery; 2. Aged>= 65 years, gender is not limited, American Society of Anesthesiologists (ASA) grade II to III; 3. Body mass index (BMI) >= 18 and = 10 and = 95% when inhaling air, SBP >= 90 mmHg, DBP >= 60 mmHg, and heart rate should be >= 60 and <= 100 beats/min; 5. Be able to understand the procedures and methods of this study, be willing to sign the informed consent form and strictly abide by the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1. Emergency surgery 2. Those with contraindications to deep sedation/general anesthesia or those with a history of sedation/anesthesia accident 3. Those who are known to be allergic to eggs, soy products, opioids and their remedies, and propofol; those with contraindications to propofol, opioids and their remedies 4. Pre-screening/baseline history or evidence of the following increased sedation/anesthesia risk: (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 after antihypertensive drug treatment and/or DBP > 100 mmHg], severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within 6 months prior to screening, tachycardia requiring drug therapy/ History of bradycardia, third-degree atrioventricular block or; (2) History of respiratory system: respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months before screening, acute respiratory infection within 1 week before baseline period, and obvious fever, Symptoms such as wheezing, nasal congestion and cough; (3) History of cerebrovascular disease: patients with craniocerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; schizophrenia, mania, insanity, long-term use of psychotropic drugs, Cognitive dysfunction history, etc.; (4) Gastrointestinal history: gastrointestinal retention, active bleeding, possible reflux and aspiration, etc.; (5) Uncontrolled disease history with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which the investigator judges 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 more than 2 units of alcohol (1 unit = 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine); (7) History of drug abuse within 3 months before the screening period. 5. The following respiratory management risks were identified during the screening period: (1) History of asthma, wheezing; (2) Patients with sleep apnea syndrome; (3) There is a history of malignant hyperthermia or family history; (4) Those who have experienced tracheal intubation failure; (5) At screening, the investigator judged that there was a difficult airway or was judged to be difficult to intubate (modified Markov score was grade IV). 6. The use of any of the following drugs or treatments was found during the screening/baseline period: (1) Participated in any drug clinical researcher within 1 month before screening; (2) Those who have used propofol, other sedative/anesthetic drugs and/or opioid analgesics or compound preparations containing analgesics within 72 hours before baseline. 7. Screening/baseline laboratory test indicators meet the following standards and are confirmed by re-examination: (1) Neutrophil count = 2.5 x ULN; (5) Total bilirubin >= 1.5 x ULN; (6) Serum creatinine >= 1.2 x ULN. 8. Subjects who are considered by the investigator to have a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| success rate of sedation / anesthesia induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of injection pain;respiratory rate;heart rate;Incidence of delayed postoperative recovery;Memory rate of endoscopic advance / retreat;postoperative sedation score; | — |
Countries
China
Contacts
Public ContactSong Dandan
The General Hospital of the Northern Theater of the Chinese People's Liberation Army
Outcome results
None listed