None listed
Conditions
Interventions
Sponsors
Pidu District People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years(including the boundary value), gender is not limited; 2. Body mass index (BMI=weight (kg)/height^2 (m^2)) within the range of 18.0-30.0kg/m^2 (including boundary values); 3. American Society of Anesthesiologists (ASA) grades I to III; 4. Patients who are going to undergo upper gastrointestinal endoscopy and need deep sedation; 5. Be aware of this study and sign the informed consent;
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 [systolic blood pressure (SBP) >=170mmHg and/or diastolic blood pressure (DBP) >=105mmHg without antihypertensive drug treatment, or SBP>160mmHg after antihypertensive drug treatment, and/or DBP>100mmHg], severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within 6 months prior to screening, history of tachycardia/bradycardia requiring medical therapy, third-degree atrioventricular block; (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 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.; uncontrolled history of diseases with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, judged by investigators that may not be suitable for participating in the study; (5) There is a history of alcoholism within 3 months before the screening period, and alcoholism means that the average daily alcohol consumption is more than 2 units of alcohol (1 unit = 360mL of beer or 45mL of liquor with an alcohol content of 40% or 150mL of wine); history of substance abuse within 3 months prior to the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of respiratory complications;Sedation success rate;Frequency of apnea; | — |
Secondary
| Measure | Time frame |
|---|---|
| MOAA/S score;Injection pain;Frequency of auxiliary ventilation;Duration of gastroscope treatment;Adverse events;Study drug use;Alternative drug use;Aldrete score;Heart rate;Blood pressure;Respiratory rate;Pulse;Pulse blood oxygen saturation; | — |
Countries
China
Contacts
Public ContactLi Junxiang
Pidu District People's Hospital
Outcome results
None listed