Digestive tract disease
Conditions
Interventions
Group 2:Propofol
Sponsors
General Hospital of Northern Theater Command
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Subjects undergoing colonoscopy; 2. ASA grade I-II, aged >= 65 years; 3. Body mass index (BMI) >= 18 and = 10 and = 95% when absorbing air; SBP >= 90 mmHg; DBP >= 60 mmHg; heart rate >= 60 and <= 100 beats/min; 5. Be able to understand the procedures and methods of this study, be willing to sign informed consent and strictly abide by the clinical research protocol to complete this study.
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 allergic to eggs, bean products, opioids and their rescue drugs, propofol, etc; contraindications of propofol, opioids and rescue drugs; 3. 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 treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg after antihypertensive treatment], severe arrhythmia, heart failure, Adams stokes syndrome, unstable angina pectoris, myocardial infarction in recent 6 months before screening; history of tachycardia/bradycardia requiring drug treatment, third degree atrioventricular block or QTCF interval >= 450 ms (corrected according to 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, and obvious symptoms such as fever, wheezing, nasal congestion and cough; (3) Cerebrovascular history: brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm and cerebrovascular accident; Schizophrenia, mania, insanity, long-term use of psychotropic drugs, history of cognitive impairment, etc.; (4) Gastrointestinal history: gastrointestinal retention, active bleeding, and possibly cause reflux and aspiration. (5) Uncontrolled diseases with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which may not be suitable for the study; (6) There was a history of alcohol abuse within 3 months prior to the screening period, i.e. an average of >2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of 40% liquor or 150 mL of wine); (7) A history of drug abuse within 3 months before the screening period; 4. The following respiratory management risks were found during the screening period: (1) Asthma history and wheezing; (2) Sleep apnea syndrome; (3) History of malignant hyperthermia or family history; (4) Those who have failed endotracheal intubation; (5) During screening, the researcher judged that there was difficult airway or was judged as difficult endotracheal intubation (modified Mahalanobis score was grade IV); 5. Any of the following drugs or treatments were found to have been used during the screening/baseline period: (1) Those who have participated in any drug clinical research within 1 month before screening; (2) Propofol, other sedative/narcotic drugs and/or opioid analgesics or compound preparations containing analgesics within 72 hours before baseline; 6. The screening/baseline laboratory inspection indicators meet the following standards and are rechecked and confirmed: (1) Neutrophil count <= 1.5 x 10^9/L; (2) Platelet count <= 80 x 10^9/L; (3) Hemoglobin <= 90 g/L (and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of sedation;Vital signs;Sedation recovery time;Total drug dosage; | — |
Countries
China
Contacts
Public ContactSong Dandan
General Hospital of Northern Theater Command
Outcome results
None listed