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

NCT ID: NCT03248076

Last Updated: 2017-12-14

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-10-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress Reaction Opioid Use

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fentanyl Citrate

Intervention Type DRUG

1γ/Kg fentanyl

Interventions

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Fentanyl Citrate

1γ/Kg fentanyl

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

32 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Papanikolaou Evaggelos

UNKNOWN

Sponsor Role collaborator

Naidecki Robert

UNKNOWN

Sponsor Role collaborator

Pakaki Fay

UNKNOWN

Sponsor Role collaborator

Raikos Nikolaos

UNKNOWN

Sponsor Role collaborator

George Papanicolaou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asouhidou Irene

Assisting Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene Asouhidou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assisting Nature

Locations

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Section of Anatomy, Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Irene Asouhidou, MD, PhD

Role: CONTACT

Phone: 00302310999321

Email: [email protected]

Evaggelos Papanikolaou, MD, PhD

Role: CONTACT

Phone: 00302310424294

Email: [email protected]

Facility Contacts

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Irene Asouhidou, MD, PhD

Role: primary

Evaggelos Papanikolaou, MD, PhD

Role: backup

References

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Bottcher B, Seeber B, Leyendecker G, Wildt L. Impact of the opioid system on the reproductive axis. Fertil Steril. 2017 Aug;108(2):207-213. doi: 10.1016/j.fertnstert.2017.06.009. Epub 2017 Jun 29.

Reference Type BACKGROUND
PMID: 28669481 (View on PubMed)

Lunger F, Vehmas AP, Furnrohr BG, Sopper S, Wildt L, Seeber B. Opiate receptor blockade on human granulosa cells inhibits VEGF release. Reprod Biomed Online. 2016 Mar;32(3):316-22. doi: 10.1016/j.rbmo.2015.12.006. Epub 2016 Jan 6.

Reference Type BACKGROUND
PMID: 26803207 (View on PubMed)

Kouvaras E, Asprodini EK, Asouchidou I, Vasilaki A, Kilindris T, Michaloudis D, Koukoutianou I, Papatheodoropoulos C, Kostopoulos G. Fentanyl treatment reduces GABAergic inhibition in the CA1 area of the hippocampus 24 h after acute exposure to the drug. Neuropharmacology. 2008 Dec;55(7):1172-82. doi: 10.1016/j.neuropharm.2008.07.025. Epub 2008 Jul 26.

Reference Type BACKGROUND
PMID: 18706433 (View on PubMed)

Other Identifiers

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Opioids-OPU

Identifier Type: -

Identifier Source: org_study_id