Menstrual Cycle Phases on Recovery and Cognitive Function
The Effects of Menstrual Cycle Phases on Recovery and Cognitive Function After General Anesthesia: A Prospective, Randomized Clinical Study
1 other identifier
observational
80
1 country
1
Brief Summary
The aim of this study was to investigate the effects of menstrual cycle phases on recovery and cognitive function after general anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2018
CompletedFirst Submitted
Initial submission to the registry
October 13, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 7, 2020
February 1, 2020
2 months
October 13, 2018
February 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive function
After general anesthesia, the time of return of the behaviors such as opening the eyes, fulfilling the orders or saying the age will be recorded and evaluated as the recovery criteria. In the postop recovery period, the patient will be subjected to mini mental state testing (MMST) and cognitive functions will be evaluated.
1 month
Study Arms (2)
Group F
Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase)
Group L
Patients with menstrual cycle between 20-24 were called Group L (Luteal phase)
Interventions
After general anesthesia, the time of return of the behaviors such as opening the eyes, fulfilling the orders or saying the age will be recorded and evaluated as the recovery criteria. In the postop recovery period, the patient will be subjected to mini mental state testing (MMST) and cognitive functions will be evaluated.
Eligibility Criteria
Current study is performed on female gender with reguler menstrual cycle, who were accepted to participate in the study,
You may qualify if:
- The study included 80 women with ASA I-II,
- Aged 18 to 45 years, who were accepted to participate in the study,
- were smoking,
- did not use oral contraceptives,
- had no menstrual irregularity (regular 28 ± 2 days menstrual cycle)
You may not qualify if:
- In preop evaluation patients had difficulties in communication,
- amenorrhea,
- pregnancy,
- delirium,
- psychological illness,
- major depressive disorder,
- patients with a history of acute illness (such as in intensive care unit follow-up),
- which may affect cognitive function and daily life activities in the last 6 months,
- malignancy,
- acute renal failure,
- substance abuse and patients older than 45 years and male sex will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, 65080, Turkey (Türkiye)
Study Officials
- STUDY CHAIR
Nureddin Yuzkat, Assist Prof
Yuzuncu Yil University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof
Study Record Dates
First Submitted
October 13, 2018
First Posted
October 17, 2018
Study Start
September 30, 2018
Primary Completion
November 30, 2018
Study Completion
December 1, 2018
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share