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Menstrual Cycle on Injection Pain of Rocuronium (MENS)

Primary Purpose

Pain, Menstrual

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rocuronium 0,6mg/kg
Rocuronium 0,6mg/kg
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain, Menstrual

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Adnan Menderes University Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Follıcular group

Luteal group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 1, 2015
Last Updated
November 28, 2017
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT02539706
Brief Title
Menstrual Cycle on Injection Pain of Rocuronium
Acronym
MENS
Official Title
The Impact of the Menstrual Cycle on Injection Pain of Rocuronium
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 6, 2014 (Actual)
Primary Completion Date
September 6, 2015 (Actual)
Study Completion Date
October 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Menstrual

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follıcular group
Arm Type
Experimental
Arm Description
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.
Arm Title
Luteal group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Rocuronium 0,6mg/kg
Other Intervention Name(s)
esmeron
Intervention Description
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
Intervention Name(s)
Rocuronium 0,6mg/kg
Other Intervention Name(s)
esmeron
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain measure
Description
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
Time Frame
10 second

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Menderes Univercity Medicine Faculty
Organizational Affiliation
Adnan Menderes University,Faculty of Medicine, Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adnan Menderes University Training and Research Hospital
City
Aydın
ZIP/Postal Code
09100
Country
Turkey

12. IPD Sharing Statement

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Menstrual Cycle on Injection Pain of Rocuronium

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