Menstrual Cycle on Injection Pain of Rocuronium

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of the Menstrual Cycle on Injection Pain of Rocuronium

Conditions
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Pain, Menstrual

Intervention / Treatment
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* Drug: Rocuronium 0,6mg/kg
* Drug: Rocuronium 0,6mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follıcular group<br>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<br>* 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<br>* Other names: esmeron;|
| Active Comparator: Luteal group<br>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<br>* 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<br>* Other names: esmeron;|

What is the study measuring?
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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 |