NCT05035069
Unknown
Phase 4
A Randomized, Single-Blinded, Parallel Single-Center Clinical Study Exploring the Efficacy and Safety of Ciprofol and Propofol for Nonintubated General Anesthesia in Patient Undergoing Transcatheter Aortic Valve Replacement (TAVR)
Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country24 target enrollmentStarted: September 3, 2021Last updated:
Overview
- Phase
- Phase 4
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Ciprofol
Experimental
Intervention: Ciprofol (Drug)
Propofol
Active Comparator
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
Time Frame: Day 1
Secondary Outcomes
- Time from the start of drug infusion to the first BIS reduction to 60(Day 1)
- Percentage of subjects received rescue treatment(Day 1)
- Time from the end of drug infusion to the recovery of BIS to 90(Day 1)
- Incidence of hypotension(Day 1)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Comparison of Propofol Target Controlled Infusion (TCI) and SevofluraneVitreous DetachmentNCT04865991Indonesia University40
Not yet recruiting
Not Applicable
Ciprofol Versus Propofol in Patients Undergoing Painless HysteroscopyPainless HysteroscopyNCT06413862Baoding First Central Hospital188
Recruiting
Not Applicable
Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort StudyCiprofolPropofolSedationLow Blood PressureNorepinephrineNCT05971121Nanfang Hospital, Southern Medical University456
Completed
Phase 4
Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).EsketamineLoop Electrosurgical ExcisionPropofolNCT06574945Qian Wu90
Not yet recruiting
Not Applicable
Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic BronchoscopyFiberoptic BronchoscopyNCT06531915Anhui Provincial Hospital190