Clinical trial NCT03708692: Menstrual Cycle Phases on Recovery and Cognitive Function
Official title: The Effects of Menstrual Cycle Phases on Recovery and Cognitive Function After General Anesthesia: A Prospective, Randomized Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cycle
Cognitive Function
Recovery
General Anesthesia
Keywords: General Anesthesia
Recovery
Cognitive Function
Menstrual Cycle phase
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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,

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive function
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van yuzuncu Yıl University, Dursun Odabas Medical Center
Study officials:
affiliation: Yuzuncu Yıl University
name: Nureddin Yuzkat, Assist Prof
role: STUDY_CHAIR
References: