sedation of gastrointestinal endoscopy
Conditions
Interventions
remimazolam group:sedation by remimazolam combined with fentanyl
propofol group:sedatioin by propofol combined with fentanyl
Sponsors
Beijing Hosipital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) patients aged =65 years (2) American Society of Anesthesiologists (ASA) physical status classification system risk class I–II (3) Body mass index (BMI) 18.0~30.0 kg/m2 (4) scheduled to undergo a gastrointestinal endoscopy under sedation (5) patient read and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)ASA=class ? (2) who were allergic to the anesthetic drugs or had a history of anesthesia-associated complications, (3) with alcohol abuse(the average daily consumption of more than 2 units of alcohol, 1 unit = 360 ml beer or 45 ml of 40% liquor or 150 ml of wine), drug abuse, long-term use of psychotropic drugs (4) History of cognitive impairment or psychiatric illness prior to examination(Including the Anxiety Self-rating Scale>50, schizophrenia, mania, bipolar disorder, mental disorders, etc) (5) who have an upper respiratory tract infection within 2 weeks before examination, with difficult airway or severe respiratory diseases (obstructive sleep apnea syndrome, mouth opening <3 cm, limited movement of the neck or jaw, morbid obesity, acute respiratory infections, acute onset of chronic obstructive pulmonary disease, and uncontrolled asthma), (6)Severe cardiovascular system diseases (who had acute heart failure, unstable angina pectoris, myocardial infarction occurred within 6 months, resting electrocardiograph (ECG) heart rate <50 beats/min, grade III atrioventricular block, severe arrhythmia, moderate to severe heart valve disease, QTc male = 450 ms, female = 470 ms) (7) Complex endoscopic procedures (e.g., endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, transoral endoscopic myotomy, etc.) (8) Pregnant or breastfeeding women, or within 3 months of family planning (including men) (9) who had participated in other studies within the previous 30 days, unwilling or unable to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time of discharge; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of successful sedation;rate of endoscopy completion;sever sedation related complication;mild sedation related complication;blood pressure and pulse during examination;induction time;number of additional drugs for induction;examination time;number of additional drugs for examnation;body movement;Injection pain;Patient satisfaction;Endoscopist satisfaction;rate of recall;QoR-15 score;RCSQ score; | — |
Countries
China
Contacts
Public ContactBing Chen
Beijing Hosipital
Outcome results
None listed