painless colonoscopy
Conditions
Interventions
one:Intravenous injection of different doses of rimaazolam
Sponsors
Traditional Chinese Medical Hospital of Zhuji
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Painless colonoscopy was performed; 2. Aged 18–65 years; 3. American anesthesiologist association ( ASA ) was graded I–II; 4. Body mass index (BMI) 18-28 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Patients with colonoscopy taboo and intestinal surgery history; 2. Evaluation of patients with difficult airway (modified Mallampati score III-IV, mouth opening less than 3 fingers, mandible, thyromental distance less than 6 cm, limited head and neck movement, sleep apnea history, etc.); 3. Patients with acute heart failure, unstable angina, and myocardial infarction within 6 months before screening; 4. Blood flow balance was not stable (systolic pressure (SBP) 180 mmHg, diastolic pressure (DBP) > 110 mmHg, and peripheral blood oxygen saturation (SpO2) < 90%); 5. Liver dysfunction (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) were higher than the 2.5 times normal upper limit, total bilirubin (TBIL) was higher than the 1.5 times normal upper limit, or renal dysfunction (arginine or arginine nitrogen was higher than the normal upper limit, serum creatine was higher than the normal upper limit); 6. Patients with previous history of psychosis, long-term use of antipsychotic drugs and cognitive impairment; 7. Patients had a long history of taking sedative and hypnotic drugs; 8. History of drug abuse and drinking (alcohol abuse: average daily consumption of more than 2 units of alcohol (1 unit = 360 mL beer or 45 mL 40 % liquor or 150 mL liquor)); 9. Pregnant or lactating women, or family planning within 3 months (including men); 10. Allergy or taboo to benzodiazepines, opioids, propofol and its components; 11. Patients who participated in other drug trials within 3 months before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90% effective dose (ED90) of remimazolam combined with alfentanyl in colonoscopy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleeping time (from ramazoline to modified observers assessment alert/sedation (MOAA/S) score 9);Flumazenil antagonism;Mean arterial pressure (MAP), respiratory rate (RR), heart rate (HR), oxygen saturation (SPO2) and BIS values at the time points of entering the ventricle (T0), 1 min after the induction of ramazulen (T1), enter the anus by colonoscopy (T2), enter the ileocecal;Incidence of adverse reactions : injection pain, hypotension (decrease > 20%), hypoxemia (SPO2 < 90%), intraoperative awareness, dizziness, nausea and vomiting, and delayed recovery; | — |
Countries
China
Contacts
Public ContactJunwei Zhao
Zhuji Hospital of Traditional Chinese Medicine
Outcome results
None listed