Menstrual Cycle Phases on Recovery and Cognitive Function

General Anesthesia Clinical Trial

Official title:

The Effects of Menstrual Cycle Phases on Recovery and Cognitive Function After General Anesthesia: A Prospective, Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708692
• Other study ID #: Menstruel Cycle Recovery
• Status: Completed
• Start date: September 30, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2020
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to investigate the effects of menstrual cycle phases on recovery and cognitive function after general anesthesia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Function
• General Anesthesia
• Menstrual Cycle
• Recovery

Intervention

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.

Locations

Country	Name	City	State
Turkey	Van yuzuncu Yil University, Dursun Odabas Medical Center	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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