Anesthesia, General
Conditions
Brief summary
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).
Detailed description
This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.
Interventions
DRUGCiprofol
Ciprofol infusion, starting with 0.8 \ 1mg/kg/h until BIS value below 60 (including 60), and then 0.2 \ 0.6mg/kg/h until the end of the operation, ciprofol infusion was adjusted to keep the BIS value between 40-60.
DRUGPropofol
Propofol infusion, starting with 4 \ 5mg/kg/h until BIS value below 60 (including 60), and then 1 \ 3mg/kg/h until the end of the operation, propofol infusion was adjusted to keep the BIS value between 40-60.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for TAVR through femoral artery access * 1h ≤ Expected duration of surgery ≤ 3h * Planned for general anesthesia without intubation * 18 ≤ BMI ≤ 30 * ASA category Ⅱ～Ⅳ
Exclusion criteria
* Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation * Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes * Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period * Hemoglobin (HB) \< 10.0 g / dl (100 g / L) * Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time that BIS value is maintained between 40 and 60 (including boundary value) | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Time from the start of drug infusion to the first BIS reduction to 60 | Day 1 |
| Time from the end of drug infusion to the recovery of BIS to 90 | Day 1 |
| Percentage of subjects received rescue treatment | Day 1 |
| Incidence of hypotension | Day 1 |
Countries
China
Contacts
Primary ContactFangqiong Li
Outcome results
None listed