Menstrual Cycle on Injection Pain of Rocuronium (MENS)

The Impact of the Menstrual Cycle on Injection Pain of Rocuronium

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.

Study Overview

• Status: Completed
• Conditions: Pain, Menstrual
• Intervention / Treatment: Drug: Rocuronium 0,6mg/kg; Drug: Rocuronium 0,6mg/kg

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Adnan Menderes University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: esmeron; 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; Other Names: esmeron
Active Comparator: 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.	Drug: 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; Other Names: esmeron; 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; Other Names: esmeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measure	Tracheal intubating dose of 0.6 mg/kg of rocuronium at room temperature was injected over 10 -15 s. The patients were observed immediately if they had pain in the arm, and the response was assessed. Withdrawal movements were also assessed and scored as follows: no movements = 0, movement limited to hand = 1, movement limited to the forearm including the elbow joint = 2, and movement of the upper arm including the shoulder joint = 3	10 second

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Adnan Menderes Univercity Medicine Faculty, Adnan Menderes University,Faculty of Medicine, Department of Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2014
• Primary Completion (Actual): September 6, 2015
• Study Completion (Actual): October 6, 2015

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: sinan