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

NCT03248076 | Unknown

• 1 other identifier: Opioids-OPU
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Reaction; Opioid Use

Outcome Measures

Primary Outcomes (1)

• fentanyl

  fentanyl on blood sample and oocyte fluid

  15 minutes

Secondary Outcomes (1)

• cortisone

  15 min

Study Arms (1)

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

Interventions

Fentanyl Citrate DRUG

1γ/Kg fentanyl

Fentanyl citrate

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers oocyte donor

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• George Papanicolaou Hospital: lead
• Papanikolaou Evaggelos: collaborator
• Naidecki Robert: collaborator
• Pakaki Fay: collaborator
• Raikos Nikolaos: collaborator

Study Sites (1)

Section of Anatomy, Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

RECRUITING

Related Publications (3)

• 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.

  PMID: 28669481 BACKGROUND

• 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.

  PMID: 26803207 BACKGROUND

• 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.

  PMID: 18706433 BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Irene Asouhidou, MD, PhD

  Assisting Nature

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Asouhidou, MD, PhD

CONTACT

00302310999321; iasouh@aol.com

Evaggelos Papanikolaou, MD, PhD

CONTACT

00302310424294; drvagpapanikolaou@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisting Professor

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 14, 2017
• Study Start: April 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: October 10, 2018
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

GR (1)