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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT03708692
Study groupRoleWhat they receive
Group FPatients with menstrual cycle between 8-12 days were called Group F (Follicular phase)
Receives: Behavioral: Group F
Group LPatients 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.

  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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start30 Sep 2018
  3. Primary completion30 Nov 2018
  4. Study completion1 Dec 2018

Resources

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)
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

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.

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