NCT03755609

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

November 16, 2018

Last Update Submit

November 27, 2018

Conditions

Conscious Sedation During Endoscopic Retrograde Choledochopancreatography

Keywords

Endoscopic Retrograde Choledochopancreatographysedationfentanyloxycodonel

Outcome Measures

Primary Outcomes (2)

  • anesthesia time

    2 days

  • operation time

    2 days

Secondary Outcomes (1)

  • irisin

    2 hours

Study Arms (2)

patients with oxycodone

ACTIVE COMPARATOR
Drug: Oxycodone

patients with fentanyl

SHAM COMPARATOR
Drug: fentanyl

Interventions

OxycodoneDRUG

0.1 mg/kg intravenously

patients with oxycodone
fentanylDRUG

1ug/kg intravenously

patients with fentanyl

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III

You may not qualify if:

  • cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33260183DERIVED

MeSH Terms

Interventions

OxycodoneFentanyl

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Qiu Zhao, MD, PhD

CONTACT

13971605755zhaoqiuwhugi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 28, 2018

Study Start

June 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

November 28, 2018

Record last verified: 2018-11

Locations

CN(1)