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

• Conditions: Opioid Use; Stress Reaction
• Interventions: Drug: Fentanyl Citrate

• Registration Number: NCT03248076
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-14
• Primary Completion: 2018-08-31
• Study Completion: 2018-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fentanyl citrate	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.

Primary Outcome Measures

Name	Time	Method
fentanyl	15 minutes	fentanyl on blood sample and oocyte fluid

Secondary Outcome Measures

Name	Time	Method
cortisone	15 min	cortisone on blood sample and oocyte fluid

Trial Locations

Locations (1)

Section of Anatomy, Aristotle University of Thessaloniki; 🇬🇷 Thessaloníki, Greece