Menstrual Cycle on Injection Pain of Rocuronium

NCT ID: NCT02539706

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-06
• Study Completion Date: 2015-10-06

Brief Summary

This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half of participants will receive follicular phase, while the other half will receive luteal phase.

Detailed Description

Menstrual period includes a spectrum of emotional and somatic symptoms observed in luteal phase of menstrual cycle, which are disappeared after menstruation.

During menstrual cycle, fluctuation in sexual hormones results in attitude change and alteration in pain perception.

Different studies reported some interactions between sex hormones and central nervous system, which might be linked to activity of serotonin and beta-endorphin in the brain.

Pain perception differs during menstrual cycle.

It has been recommended that estrogens might have an influence on somatic sensory process.

Some studies reported a significant effect of pain sensitivity with higher levels of progesterone and some other studies reported similar patterns for pain perception.

There are reports of more complaint of pain in luteal phase of menstruation, which is suggested as the reason for functional changes in women during menstrual cycle.

Conditions

Pain, Menstrual

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Follıcular group

patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.

Group Type: EXPERIMENTAL

Rocuronium 0,6mg/kg

Intervention Type: DRUG

patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous was applied

Luteal group

patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.

Group Type: ACTIVE_COMPARATOR

Rocuronium 0,6mg/kg

Intervention Type: DRUG

patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied

Interventions

Rocuronium 0,6mg/kg

patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous was applied

Intervention Type: DRUG

Rocuronium 0,6mg/kg

patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied

Intervention Type: DRUG

Other Intervention Names

esmeron; esmeron

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiology Classification (ASA) I-II
• 18-45 years
• Regular menstrual cycle

Exclusion Criteria

• Irregular menstrual cycles
• Patients receiving hormones or drugs affecting the ovulatory cycle
• Amenorrhea
• Pregnancy
• Climacteric patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

SİNAN YILMAZ

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adnan Menderes Univercity Medicine Faculty

Role: PRINCIPAL_INVESTIGATOR

Adnan Menderes University,Faculty of Medicine, Department of Anesthesia

Locations

Adnan Menderes University Training and Research Hospital

Aydin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

sinan

Identifier Type: -

Identifier Source: org_study_id