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Effect of Fentanyl on Main Opioid Receptor (OPRM1) on Human Granulosa Cells.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248076
Recruitment Status : Unknown
Verified December 2017 by Asouhidou Irene, George Papanicolaou Hospital.
Recruitment status was:  Recruiting
First Posted : August 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborators:
Papanikolaou Evaggelos
Naidecki Robert
Pakaki Fay
Raikos Nikolaos
Information provided by (Responsible Party):
Asouhidou Irene, George Papanicolaou Hospital

Brief Summary:

Opioids is known that produce not only analgesia but also hyperalgesia through activation of central glutaminergic system-GABA. At the same time, recently it was found that the main opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production via OPRM1, causing ovarian hyperstimulation syndrome.

This study aims to investigate if a single exposure to opioids is enough to produce activation of stress mechanism during oocyte retrieval.


Condition or disease Intervention/treatment
Stress Reaction Opioid Use Drug: Fentanyl Citrate

Detailed Description:

The main opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production via OPRM1, causing ovarian hyperstimulation syndrome.

This study aims to investigate if a single exposure to opioids is enough to produce activation of stress mechanism during ultrasound-guided oocyte retrieval. It will be measured the level of cortisone before and 15min after iv administration of fentanyl on blood and on oocyte fluid.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Fentanyl on Expression of Main Opioid Receptor (OPRM1) on Human Granulosa Cells During Ultrasound-guided Transvaginal Oocyte Retrieval.
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Fentanyl citrate
Baseline blood sample and oocyte fluid will be collected under propofol anesthesia. Fifteen minutes after administration of 1γ/kgfentanyl, it will be collected again blood sample and oocyte fluid. Cortisone and fentanyl level will be measured in all samples.
Drug: Fentanyl Citrate
1γ/Kg fentanyl




Primary Outcome Measures :
  1. fentanyl [ Time Frame: 15 minutes ]
    fentanyl on blood sample and oocyte fluid


Secondary Outcome Measures :
  1. cortisone [ Time Frame: 15 min ]
    cortisone on blood sample and oocyte fluid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers oocyte donor
Criteria

Inclusion Criteria:

  • American Physical Status I-III, BMI<30,

Exclusion Criteria:

  • Heart failure
  • hepatic failure, hepatitis,
  • drug abuse
  • receiving b blockers
  • receiving b agonists (even bronchodilators)

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): NCT03248076


Contacts
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Contact: Irene Asouhidou, MD, PhD 00302310999321 iasouh@aol.com
Contact: Evaggelos Papanikolaou, MD, PhD 00302310424294 drvagpapanikolaou@yahoo.gr

Locations
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Greece
Section of Anatomy, Aristotle University of Thessaloniki Recruiting
Thessaloníki, Greece, 54124
Contact: Irene Asouhidou, MD, PhD    2310999321    iasouh@aol.com   
Contact: Evaggelos Papanikolaou, MD, PhD    +302310424294    drvagpapanikolaou@yahoo.gr   
Sponsors and Collaborators
George Papanicolaou Hospital
Papanikolaou Evaggelos
Naidecki Robert
Pakaki Fay
Raikos Nikolaos
Investigators
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Principal Investigator: Irene Asouhidou, MD, PhD Assisting Nature

Publications:
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Responsible Party: Asouhidou Irene, Assisting Professor, George Papanicolaou Hospital
ClinicalTrials.gov Identifier: NCT03248076     History of Changes
Other Study ID Numbers: Opioids-OPU
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries
Fentanyl
Citric Acid
Sodium Citrate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action