Menstrual Cycle Phases on Recovery and Cognitive Function

February 5, 2020 updated by: Nureddin YUZKAT, Yuzuncu Yıl University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey, 65080
        • Van Yüzüncü Yıl University, Dursun Odabaş Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Current study is performed on female gender with reguler menstrual cycle, who were accepted to participate in the study,

Description

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)

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group F
Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase)
Behavioral: Group F
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.
Other Names:
  • Group L
Group L
Patients with menstrual cycle between 20-24 were called Group L (Luteal phase)
Behavioral: Group F
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.
Other Names:
  • Group L

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nureddin Yuzkat, Assist Prof, Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Menstruel Cycle Recovery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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