Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 5:40 PM
Study NCT ID:
NCT06719960
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2024-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Patients?
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Endoscopic Retrograde Cholangiopancreatography Patients?
Status:
COMPLETED
Status Verified Date:
2024-12
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:
The investigators wanted to observe the change in the level of consciousness of patients undergoing ERCP after anesthesia. For this, the investigators evaluated the patients with the mini mental state examination test and the frail scale.
Detailed Description:
Background and Aim: For patients, endoscopic retrograde cholangiopancreatography (ERCP) is a painful procedure and requires deeper sedation and less body movement than routine gastrointestinal endoscopy. Different sedation methods can be used during the ERCP procedure, which is increasingly used in elderly patients, but their effects on cognitive functions are not clearly known. The main aim of our study was to observe the effect of different sedation methods routinely used in geriatric ERCP patients on cognitive functions.
Methods: Our observational prospective study included 184 inpatients aged 65 years and older who received propofol or propofol + dexmedetomidine for sedation during ERCP. To evaluate cognitive function, Mini Mental State Examination (MMSE) was administered 3 times before the procedure and 2 hours and 24 hours after the procedure. Frailty level of the patient was determined using the frail frailty questionnaire. Each patient received 0.5µg/kg fentanyl (iv). In the propofol group, propofol loading dose: 0.2-0.5mg/kg, maintenance infusion dose: 0.5-4mg/kg/h was continued. In the dexmedetomidine group, in addition to propofol infusion at the same doses, dexmedetomidine 0.5 μg/kg-1 loading dose was administered within 10 minutes and then continued as infusion at a dose of 0.2-0.7 μg/kg/h. Ramsey score was kept at 3-4. ERCP procedure time, total amount of propofol and dexmedetomidine used, atropine and ephedrine administered additionally were recorded.
Methods: Our observational prospective study included 184 inpatients aged 65 years and older who received propofol or propofol + dexmedetomidine for sedation during ERCP. To evaluate cognitive function, Mini Mental State Examination (MMSE) was administered 3 times before the procedure and 2 hours and 24 hours after the procedure. Frailty level of the patient was determined using the frail frailty questionnaire. Each patient received 0.5µg/kg fentanyl (iv). In the propofol group, propofol loading dose: 0.2-0.5mg/kg, maintenance infusion dose: 0.5-4mg/kg/h was continued. In the dexmedetomidine group, in addition to propofol infusion at the same doses, dexmedetomidine 0.5 μg/kg-1 loading dose was administered within 10 minutes and then continued as infusion at a dose of 0.2-0.7 μg/kg/h. Ramsey score was kept at 3-4. ERCP procedure time, total amount of propofol and dexmedetomidine used, atropine and ephedrine administered additionally were recorded.
Study Oversight
Has Oversight DMC:
False
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?: