Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015074
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-06-21
Brief Title:
Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography ERCP In the past decade many practices have been carried out under the propofol-based monitored anesthesia care without endotracheal intubation in patients undergoing ERCP
Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of propofol Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the evidence supported its application in ERCP is still limited
Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of propofol Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the evidence supported its application in ERCP is still limited
Detailed Description:
This is a prospective randomized double-blind trial comparing the incidence of hypoxia in the propofol versus ciprofol intravenous Anesthesia A total 136 patients will be recruited and randomly assigned to either the propofol or the ciprofol group The primary outcome is the proportion of patients experiencing hypoxia The secondary outcomes include the incidence of hypotension in perioperative period the incidence of conversion from intravenous anesthesia to general anesthesia sedation-related procedure interruption carbon dioxide CO2 accumulation during operation Patients satisfaction with anesthesia and postoperative recovery VAS score incidence of nausea and vomiting the incidence of intraoperative and postoperative adverse events such as adverse excretion severe hypoxemia severe circulatory dysfunction length of stay and mortality within 30 days after operation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None