- ICH GCP
- US Clinical Trials Registry
- 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
November 27, 2018 updated by: fangjun, Changhai Hospital
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
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
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qiu Zhao, MD, PhD
- Phone Number: 13971605755
- Email: zhaoqiuwhugi@gmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Recruiting
- Changhai Hospital
-
Contact:
- bai bai, M.D
- Phone Number: 021-81873241
- Email: baiyu1998@hotmail.com
-
Contact:
- fang jun, M.D
- Phone Number: 021-81873241
- Email: XHFANGJUN@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I-III
Exclusion Criteria:
- cardiovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: patients with oxycodone
|
0.1 mg/kg intravenously
|
Sham Comparator: patients with fentanyl
|
1ug/kg intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
anesthesia time
Time Frame: 2 days
|
2 days
|
operation time
Time Frame: 2 days
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
irisin
Time Frame: 2 hours
|
serum levels of irisin
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
November 16, 2018
First Submitted That Met QC Criteria
November 27, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
November 28, 2018
Last Update Submitted That Met QC Criteria
November 27, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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