Menstrual Cycle on Injection Pain of Rocuronium

Pain, Menstrual Clinical Trial

— MENS  

Official title:

The Impact of the Menstrual Cycle on Injection Pain of Rocuronium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539706
• Other study ID #: sinan
• Status: Completed
• Phase: N/A
• First received: September 1, 2015
• Last updated: November 28, 2017
• Start date: January 6, 2014
• Est. completion date: October 6, 2015

Study information

• Verified date: November 2017
• Source: Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 6, 2015
• Est. primary completion date: September 6, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Pain, Menstrual

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Training and Research Hospital	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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