Clinical trial NCT03755609: Efficacy of Oxycodone-propofol Combination Compared With a Fentanyl-propofol Combination on Conscious Sedation Effect and Early Cognitive Function During Therapeutic Endoscopic Retrograde Cholangio-pancreatography
Official title: Efficacy of Oxycodone-propofol Combination Compared With a Fentanyl-propofol Combination on Conscious Sedation Effect and Early Cognitive Function During Therapeutic Endoscopic Retrograde Cholangio-pancreatography:a Prospective,Randomized, Single- Blinded Preliminary Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Conscious Sedation During Endoscopic Retrograde Choledochopancreatography
Keywords: Endoscopic Retrograde Choledochopancreatography
sedation
fentanyl
oxycodonel
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan University
First posted: 2018-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate and compare the sedative effect and effects on early period cognitive function of a fentanyl-propofol Combination (FP) regimen with a oxycodone-propofol(OP) combination during the endoscopic retrograde cholangio-pancreatography (ERCP) requiring conscious sedation

Detailed description: One hundred patients undergoing ERCP were included in this study and randomly divided into two groups of 50 people each. The patients in group FP were given fentanyl infusion of 1ug/kg intravenously 5 minutes before the process. They were given propofol infusion: a loading does of 1-2mg/kg immediately before the process then maintenance does of 1mg/kg/h. The patients in group OP were administered oxycodone of 0.1 mg/kg and 1-2mg/kg loading dose of propofol intravenously 5 minutes before the process. Then they were given 1mg/kg/h maintenance does of propofol infusion. In order to maintenan Ramsey Sedation Scale (RSS) between 3 and 4, all patients were administered 0.2\~0.5 mg/kg bolus of propofol when necessary. Time of induction of anesthesia, operation time, wake-up time, recovery time, occurrence of adverse cardiovascular events, bucking, nausea and vomiting and respiratory depression ,total dosage of used propofol were assessed.Furthermore,different time point of regional cerebral oxygen saturation (rScO2) ,serum levels of irisin and cognitive function by mini-mental state examination (MMSE) were rated.

Eligibility criteria: Inclusion Criteria:

* ASA I-III

Exclusion Criteria:

* cardiovascular disease

Primary outcomes:
measure: anesthesia time
timeFrame: 2 days
measure: operation time
timeFrame: 2 days
Secondary outcomes:
measure: irisin
timeFrame: 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Guo P, Wu H, Liu L, Zhao Q, Jin Z. Efficacy of an Oxycodone-Propofol Combination versus a Fentanyl-Propofol Combination in Conscious Sedation during Therapeutic Endoscopic Retrograde Cholangiopancreatography in Elderly Patients. Gerontology. 2021;67(1):9-16. doi: 10.1159/000511173. Epub 2020 Dec 1.