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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

NCT ID: NCT03755609

Last Updated: 2018-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Conscious Sedation During Endoscopic Retrograde Choledochopancreatography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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patients with oxycodone

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

0.1 mg/kg intravenously

patients with fentanyl

Group Type SHAM_COMPARATOR

fentanyl

Intervention Type DRUG

1ug/kg intravenously

Interventions

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Oxycodone

0.1 mg/kg intravenously

Intervention Type DRUG

fentanyl

1ug/kg intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I-III

Exclusion Criteria

* cardiovascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan University

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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fangjun

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiu Zhao, MD, PhD

Role: CONTACT

[email protected]
13971605755

Facility Contacts

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bai bai, M.D

Role: primary

[email protected]
021-81873241

fang jun, M.D

Role: backup

[email protected]
021-81873241

References

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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.

Reference Type DERIVED
PMID: 33260183 (View on PubMed)

Other Identifiers

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2018006

Identifier Type: -

Identifier Source: org_study_id

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