Gastroenteroscopy sedation/anesthesia
Conditions
Interventions
Group C:Remifentanil was injected intravenously at 0.15µg/kg (the drug concentration was 1µg/ml, the infusion time was 10 s±5s), and the investigational drug cyclopofol was injected intravenously at 0
Group EP:Remifentanil was injected intravenously at 0.15µg/kg (the drug concentration was 1µg/ml, the infusion time was 10 s±5s), and the mixture of etomidate and propofol was injected intravenously a
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Subjects receiving painless gastroenteroscopy; 2) Male or female, ASA grade I-III, age = 65 years; 3) Body mass index (BMI) =18 and < 30 kg/m2; 4) Blood oxygen saturation (SpO2) = 95% when breathing air during the screening period; SBP = 90 mmHg; DBP = 60 mmHg; Heart rate should be = 60 and = 100 beats/min; 5) Able to understand the procedures and methods of this study, willing to sign informed consent and strictly follow the clinical study protocol to complete this study.
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications to deep sedation/general anesthesia or who have a history of sedation/anesthesia accidents in the past; 2) People who are known to be allergic to eggs, soy products, opioids and their relief drugs, and propofol; Propofol, opioids and their relief drugs contraindicated; 3) History or evidence of the following increased risk of sedation/anesthesia during the pre-screening/baseline period: a) Cardiovascular history: Uncontrolled hypertension [systolic blood pressure (SBP) =170 mmHg and/or diastolic blood pressure (DBP) =105 mmHg without antihypertensive medication, Or SBP > 160 mmHg and/or DBP > 100 mmHg] after treatment with antihypertensive drugs, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, nearly 6 Myocardial infarction, a history of medically treated tachycardia/bradycardia, third-degree atrioventricular block, or QTcF interval = 450 ms (adjusted by Fridericia's formula) within the first month; b) Respiratory history: respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory infection within 1 week prior to baseline, with obvious symptoms such as fever, wheezing, nasal congestion, and cough; c) History of neuropsychiatric system: craniocerebral injury, possible history of convulsion, intracranial hypertension, brain aneurysm, cerebrovascular accident; Schizophrenia, mania, insanity, long-term use of psychotropic drugs, history of consciousness disorders, history of cognitive dysfunction, etc.; d) Gastrointestinal history: gastrointestinal retention, active bleeding, possible reflux aspiration, etc.; e) uncontrolled history of clinically significant diseases of the liver, kidney, blood system, nervous system, or metabolic system that investigators judge may not be suitable for study participation; f) a history of alcohol abuse within the 3 months prior to the screening period, defined as average daily alcohol consumption > 2 units of alcohol (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine); g) a history of drug abuse within 3 months prior to the screening period; 4) The following respiratory management risks were found during the screening period: a) History of asthma, wheezing; b) Patients with sleep apnea syndrome; c) A history or family history of malignant hyperthermia; d) Patients with tracheal intubation failure; e) During screening, difficult airway was judged by the investigator or endotracheal intubation was difficult (modified Markov score level IV); 5) Any of the following drugs or treatments were found to have been used during the screening/baseline period: a) Participated in any drug clinical investigator within 1 month prior to screening; b) use of propofol, other sedative/narcotic drugs and/or opioid analgesics or combination formulations containing analgesics within 72 hours prior to baseline; 6) Patients with contraindications of routine endoscopic procedures; 7) Subjects with any other factors deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of gastroscopy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Awakening Time;Duration of successful induction of sedation/anesthesia;Incidence of injection pain;Incidence of muscle fibrillation;Incidence of respiratory adverse events;Incidence of hypotension requiring intervention;Evaluation of doctor/patient satisfaction;Incidence of PONV;Postoperative cognitive function changes; | — |
Countries
China
Contacts
Public Contactxv junjun
Peking University People's Hospital
Outcome results
None listed