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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

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ClinicalTrials.gov Identifier: NCT03755609
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Wuhan University
Information provided by (Responsible Party):
fangjun, Changhai Hospital

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

Condition or disease Intervention/treatment Phase
Conscious Sedation During Endoscopic Retrograde Choledochopancreatography Drug: Oxycodone Drug: fentanyl Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: patients with oxycodone Drug: Oxycodone
0.1 mg/kg intravenously

Sham Comparator: patients with fentanyl Drug: fentanyl
1ug/kg intravenously




Primary Outcome Measures :
  1. anesthesia time [ Time Frame: 2 days ]
  2. operation time [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. irisin [ Time Frame: 2 hours ]
    serum levels of irisin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III

Exclusion Criteria:

  • cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755609


Contacts
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Contact: Qiu Zhao, MD, PhD 13971605755 zhaoqiuwhugi@gmail.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: bai bai, M.D    021-81873241    baiyu1998@hotmail.com   
Contact: fang jun, M.D    021-81873241    XHFANGJUN@163.com   
Sponsors and Collaborators
Changhai Hospital
Wuhan University

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Responsible Party: fangjun, physician, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03755609     History of Changes
Other Study ID Numbers: 2018006
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

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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

Keywords provided by fangjun, Changhai Hospital:
Endoscopic Retrograde Choledochopancreatography
sedation
fentanyl
oxycodonel

Additional relevant MeSH terms:
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Oxycodone
Propofol
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia