anaesthesia of elderly gastroscopic patients
Conditions
Interventions
Group 2:Propofol
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects who received gastroscopic diagnosis and treatment; 2. No gender limit, ASA class I-III, aged >= 65 years; 3. Body mass index (BMI) >=18 and = 95% when breathing air; SBP >= 90 mmHg; DBP >= 60 mmHg; heart rate should be 60-100 beats/min; 5. Be able to understand the procedures and methods of this research, be willing to sign the informed consent form and strictly follow the clinical research protocol to complete this research.
Exclusion criteria
Exclusion criteria: 1. Those with contraindications to deep sedation/general anesthesia or those who have had a history of sedation/anesthesia accident in the past; 2. 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; 3. Pre-screening/baseline history or evidence of the following increased sedation/anesthesia risk: (1) Cardiovascular history: uncontrolled hypertension [without antihypertensive drug treatment systolic blood pressure (SBP) >= 170 mmHg and/or diastolic blood pressure (DBP) >= 105 mmHg, or SBP>160 mmHg and/or DBP>100 mmHg] after antihypertensive drug treatment, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the last 6 months prior to screening, history of tachycardia/bradycardia requiring medical therapy, third-degree atrioventricular block, or QTcF interval >= 450 ms (corrected by Fridericia's formula); (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 have obvious symptoms such as fever, wheezing, nasal congestion and cough; (3) History of neuropsychiatric system: subjects with craniocerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; schizophrenia, mania, insanity, long-term use of psychotropic drugs, history of disorder of consciousness, history of cognitive dysfunction, etc.; (4) Gastrointestinal history: Gastrointestinal retention, active bleeding, possible reflux and aspiration, etc.; (5) Uncontrolled history of diseases 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, and alcoholism means drinking more than 2 units of alcohol on average per day (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; 4. The following respiratory management risks were identified during the screening period: (1) History of asthma, wheezing; (2) Subjects with sleep apnea syndrome; (3) Have a history of malignant hyperthermia or family history; (4) Those who have failed tracheal intubation; (5) Difficult airway or tracheal intubation was judged by the investigator at the time of screening (modified Markov score was grade IV); 5. 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 analgesic ingredients within 72 hours before baseline; 6. Those with contraindications to routine endoscopic operation; 7. Subjects who are considered by the investigator to have any other factors that are not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| respiratory depression;apnea;hypoxia; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of successful sedation;Duration of diagnosis and treatment;Full awake time;Evaluation of subjects' satisfaction with sedation/anesthesia;Evaluation of subjects' acceptance of narcotic drugs;Safety evaluation; | — |
Countries
China
Contacts
Public ContactZhu Tao, Zhang Xiang
West China Hospital, Sichuan University
Outcome results
None listed