Menstrual CycleNCT03708692
Menstrual Cycle Phases on Recovery and Cognitive Function
An observational study of Menstrual Cycle and Cognitive Function, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of menstrual cycle phases on recovery and cognitive function after general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrual Cycle, Cognitive Function, Recovery
- What is being tested?
- Group F
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2018to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Current study is performed on female gender with reguler menstrual cycle, who were accepted to participate in the study,
Who may be able to join
- 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)
Who cannot join
- In preop evaluation patients had difficulties in communication,
- amenorrhea,
- pregnancy,
- delirium,
- psychological illness,
- major depressive disorder,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, 65080
About this study
Official title: The Effects of Menstrual Cycle Phases on Recovery and Cognitive Function After General Anesthesia: A Prospective, Randomized Clinical Study
The aim of this study was to investigate the effects of menstrual cycle phases on recovery and cognitive function after general anesthesia.
Read the detailed description
Study Protocol, Methods and Procedures to be Applied:
The study was started after obtaining the approval of the Ethics Committee, the written approvals of the patients The study is planned to conduct between October 2018- December 2018.
The study groups were selected from patients who presented to the preop anesthesia polyclinic in elective conditions, septo-rinoplasty operation under general anesthesia.
The study groups will be selected from patients who presented to the preop anesthesia polyclinic in elective conditions, septo-rinoplasty operation under general anesthesia. Assuming that there would be a 5-point difference in anxiety scores among the groups, it was decided to take 45 cases for each group with a 0.75 standard effect size, 80% power, and 5% error. Patients will be randomly assigned to 2 groups of 45 people according to their order of application. Patients will be randomized by inclusion into the determined groups. At the day of surgery, the inclusion of the patient into the one of the group will be decided.
Study inclusion criteria: 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).
Study exclusion criteria: 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.
Groups:
Information about menstrual cycle patterns was obtained from all cases. The days of the menstrual cycle will be determined starting from counting the first day of the last cycle. Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase). Patients with menstrual cycle between 20-24 were called Group L (Luteal phase). The follow-up of the cases and the recording of the measurements were performed by an anesthesiologist who did not know which group the cases were in.
Procedures to be Applied:
Patients' gender, age, height, weight values, ASA scores, body mass index (BMI) values will be recorded.
Preoperative anesthetic examinations of the patients to be included in the study will be done at the anesthesia clinic at least 1 day before the operation. The preop tests that will be required after the examinations will consist of routine examinations.
In the operation room, hemodynamic parameters will be recorded at 5-minute intervals before induction, after intubation.
Routine procedures that is applied to similar patients will be followed during extubation of patients. The inside of the mouth will be aspirated before extubation and the patient will be extubated after muscle strength and consciousness's are restored.
Total anesthesia duration and total surgical duration, postoperative agitation, laryngospasm, hypoxia, nausea and vomiting frequency will be recorded.
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.
- Conditions
- Menstrual Cycle, Cognitive Function, Recovery, General Anesthesia
- Being tested
- Group F
- Keywords
- General Anesthesia, Recovery, Cognitive Function, Menstrual Cycle phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group FBehavioural
Also called Group L
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.
| Study group | Role | What they receive |
|---|---|---|
| Group F | Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase) Receives: Behavioral: Group F | |
| Group L | Patients with menstrual cycle between 20-24 were called Group L (Luteal phase) Receives: Behavioral: Group F |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start30 Sep 2018
- Primary completion30 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nureddin YUZKAT, Yuzuncu Yil University
- Investigators
- Nureddin Yuzkat, Assist Prof, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708692
- Sponsor's protocol ID
- Menstruel Cycle Recovery
- Status last verified
- Feb 2020
- First submitted
- 13 Oct 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Menstrual Cycle Phases on Recovery and Cognitive Function After General Anesthesia: A Prospective, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03708692
- Acronym / sponsor ID
- Menstruel Cycle Recovery
- Conditions
- Menstrual Cycle, Cognitive Function, Recovery, General Anesthesia
- Keywords
- General Anesthesia, Recovery, Cognitive Function, Menstrual Cycle phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to investigate the effects of menstrual cycle phases on recovery and cognitive function after general anesthesia.
Detailed description
Study Protocol, Methods and Procedures to be Applied:
The study was started after obtaining the approval of the Ethics Committee, the written approvals of the patients The study is planned to conduct between October 2018- December 2018.
The study groups were selected from patients who presented to the preop anesthesia polyclinic in elective conditions, septo-rinoplasty operation under general anesthesia.
The study groups will be selected from patients who presented to the preop anesthesia polyclinic in elective conditions, septo-rinoplasty operation under general anesthesia. Assuming that there would be a 5-point difference in anxiety scores among the groups, it was decided to take 45 cases for each group with a 0.75 standard effect size, 80% power, and 5% error. Patients will be randomly assigned to 2 groups of 45 people according to their order of application. Patients will be randomized by inclusion into the determined groups. At the day of surgery, the inclusion of the patient into the one of the group will be decided.
Study inclusion criteria: 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).
Study exclusion criteria: 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.
Groups:
Information about menstrual cycle patterns was obtained from all cases. The days of the menstrual cycle will be determined starting from counting the first day of the last cycle. Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase). Patients with menstrual cycle between 20-24 were called Group L (Luteal phase). The follow-up of the cases and the recording of the measurements were performed by an anesthesiologist who did not know which group the cases were in.
Procedures to be Applied:
Patients' gender, age, height, weight values, ASA scores, body mass index (BMI) values will be recorded.
Preoperative anesthetic examinations of the patients to be included in the study will be done at the anesthesia clinic at least 1 day before the operation. The preop tests that will be required after the examinations will consist of routine examinations.
In the operation room, hemodynamic parameters will be recorded at 5-minute intervals before induction, after intubation.
Routine procedures that is applied to similar patients will be followed during extubation of patients. The inside of the mouth will be aspirated before extubation and the patient will be extubated after muscle strength and consciousness's are restored.
Total anesthesia duration and total surgical duration, postoperative agitation, laryngospasm, hypoxia, nausea and vomiting frequency will be recorded.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | – | Behavioral: Group FPatients with menstrual cycle between 8-12 days were called Group F (Follicular phase) |
| Group L | – | Behavioral: Group FPatients with menstrual cycle between 20-24 were called Group L (Luteal phase) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Current study is performed on female gender with reguler menstrual cycle, who were accepted to participate in the study,
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- In preop evaluation patients had difficulties in communication,
- amenorrhea,
- pregnancy,
- delirium,
- psychological illness,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group FAlso: Group LAfter 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. | Behavioural | Group F, Group L |
Primary outcome
Cognitive function
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nureddin Yuzkat, Assist Prof study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Cognitive Function, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.