Colonoscopy
Conditions
Interventions
Remimazolam group:Fentanyl 1ug/kg was administered to patients by intravenous injection before the assigned trial sedatives. Give the initial dose of 5.0 mg of remimazolam. If sufficient sedation is n
Propofol Group:Fentanyl 1ug/kg was administered to patients by intravenous injection before the assigned trial sedatives. An initial dose of 1.5 mg/kg of propofol is given. If sufficient sedation is n
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Planned to undergo outpatient colonoscopy; 2. Age >=18 years; 3. American Society of Anesthesiologists (ASA) physical status I-III; 4. Patients voluntarily participate in the trial and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. About to receive endotracheal intubation or laryngeal mask; 2. Required complex endoscope procedures (such as endoscopic submucosal dissection, etc.); 3. Psychiatric disorders (schizophrenia, mania, etc.) and cognitive impairment; 4. History of drug/alcohol abuse within two years (Alcohol abuse: average daily consumption of more than 2 units of alcohol, 1 unit of alcohol = 360 mL5% beer or 45 mL 40% liquor or 150 mL 10-15% red wine); 5. Pregnant or breastfeeding women; 6. Known sensitivity or contraindication to benzodiazepines, opioids and propofol; 7. Unable to understand the recovery quality scale and difficult to complete the recovery quality survey.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of overall recovery (recovery in all subdomains) of the PostopQRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery across all time points over 3 months for each PostopQRS domain and overall recovery;Patient satisfaction and endoscopist satisfaction with surgical conditions;Incidence of adverse events, including hypotension (SBP or DBP <80% of the baseline), bradycardia (HR<50bpm), hypoxia (SpO2<90%), injection site pain, dizziness, abnormal gait, nausea and vomiting and diarrhea;Induction time of sedation (from administration to meet the colonoscopy requirements), sedation duration (from administration to eye opening), time to eye-opening (from the last dose to eye opening), and time to discharge from the recovery room (from the end of colonoscopy to leave the recovery room); | — |
Countries
China
Contacts
Public Contactunyi i
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed