Conscious Sedation During Endoscopic Retrograde CholedochopancreatographyNCT03755609
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 study testing Oxycodone and fentanyl in people with Conscious Sedation During Endoscopic Retrograde Choledochopancreatography, run by Changhai Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Conscious Sedation During Endoscopic Retrograde Choledochopancreatography
- What is being tested?
- Oxycodone and fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
Who cannot join
- cardiovascular disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
bai bai, M.D, 021-81873241, baiyu1998@hotmail.com
fang jun, M.D, 021-81873241, XHFANGJUN@163.com
About this study
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
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
Read the 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.
- Keywords
- Endoscopic Retrograde Choledochopancreatography, sedation, fentanyl, oxycodonel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with oxycodone | Active comparator | Not described Receives: Drug: Oxycodone |
| patients with fentanyl | Sham comparator | Not described Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthesia time
Measured: 2 days
operation time
Measured: 2 days
Secondary outcomes (1)
irisin
serum levels of irisin
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Jun 2018
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conscious Sedation During Endoscopic Retrograde CholedochopancreatographyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan University
- Responsible party
- Principal investigator, fangjun, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755609
- Sponsor's protocol ID
- 2018006
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33260183
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03755609
- Acronym / sponsor ID
- 2018006
- Keywords
- Endoscopic Retrograde Choledochopancreatography, sedation, fentanyl, oxycodonel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Wuhan University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with oxycodone | Active comparator | Drug: Oxycodone |
| patients with fentanyl | Sham comparator | Drug: fentanyl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III
Key exclusion criteria (1 listed)
- cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone0.1 mg/kg intravenously | Drug | patients with oxycodone |
| fentanyl1ug/kg intravenously | Drug | patients with fentanyl |
Primary outcome
anesthesia time
Time frame: 2 days
operation time
Time frame: 2 days
1 secondary outcome
irisin
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Derived from this study: PubMed 33260183Guo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone and fentanyl in people with Conscious Sedation During Endoscopic Retrograde Choledochopancreatography, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiu Zhao, MD, PhD (13971605755, zhaoqiuwhugi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anesthesia time (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.