None
Conditions
Interventions
Remimazolam besylate in combination with alfentanil group:None
Sponsors
Zhongyi Northeast International Hospital Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who intend to undergo colonoscopy; 2. Male or female subjects between the ages of 18 and 80 years (including cut-off values), body mass index (BMI) >=18; 3. If a woman of childbearing age, it should be non-pregnant or lactating; 4. American Society of Anesthesiologists (ASA) grade I~III; 5. Surgery time: 10~30 minutes; 6. (Willing and able to comply with clinical visits and study-related procedures; 7. Subjects must be able to read and understand and be willing to sign the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Combined with severe cardiovascular and cerebrovascular diseases and liver and kidney dysfunction; 2. High risk of reflux aspiration; 3. Long-term use of sedatives and analgesics in the past; 4. Those who do not cooperate and cannot communicate; 5. Allergy to the drug in this study; 6. Have recently participated in other clinical studies; 7. Recent or ongoing upper respiratory tract infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite adverse events(Hypotension+Hypoxia+Bradycardia); | — |
Secondary
| Measure | Time frame |
|---|---|
| Anesthesia-related parameters(Induction time;Procedure time ;Emergence time;Post-anesthesia care unit (PACU) discharge time);End - tidal carbon dioxide;Colonoscopy success rate;Other efficacy endpoints:Number of intraoperative rescue medication administrations;Total remimazolam dosage;Other intraoperative adverse events(Muscle tremor?Coughing?Hiccups?Hypertension ?Tachycardia ?Intraoperative awareness ? Prolonged sedation);Postoperative Follow-up;Basic information: gender, age, height, weight, BMI;ASA Classification(American Society of Anesthesiologists Classification);EEG Bispectral Index;Respiratory Rate;The satisfaction of patients and doctors;Heart rate;Postoperative adverse events:Abdominal pain (assessed by NRS score after colonoscopy);Somnolence;Dizziness;Incidence of nausea and vomiting (PONV); | — |
Countries
China
Contacts
Public ContactYu Wang
Zhongyi Northeast International Hospital Co., Ltd
Outcome results
None listed