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
The aim of this study was to investigate the effects of menstrual cycle phases on recovery and cognitive function after general anesthesia.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04577430 -
Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period
|
N/A | |
Recruiting |
NCT03422315 -
Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection
|
N/A | |
Completed |
NCT02771067 -
The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position
|
N/A | |
Completed |
NCT05063461 -
Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
|
N/A | |
Completed |
NCT03294226 -
Comparison of AuraGain With I-gel for Pediatric Patients
|
N/A | |
Not yet recruiting |
NCT03643029 -
The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy
|
N/A | |
Completed |
NCT01945411 -
Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway
|
N/A | |
Completed |
NCT01705743 -
Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG
|
Phase 4 | |
Not yet recruiting |
NCT01678066 -
A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor
|
N/A | |
Completed |
NCT00972491 -
The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia
|
N/A | |
Completed |
NCT00741507 -
Unhealthy Alcohol Drinking and Anesthetic Requirement in Women
|
N/A | |
Completed |
NCT01096212 -
Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia
|
Phase 4 | |
Completed |
NCT00532402 -
Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas
|
N/A | |
Completed |
NCT00599066 -
Intraoperative M-Entropy Measurements
|
N/A | |
Completed |
NCT00468494 -
Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?
|
N/A | |
Recruiting |
NCT00492453 -
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
|
N/A | |
Recruiting |
NCT03745079 -
Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
|
||
Completed |
NCT04094376 -
Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
|
N/A | |
Enrolling by invitation |
NCT03672734 -
Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia
|
||
Recruiting |
NCT04926220 -
Dynamic Estimation of Cardiac Output in the Operating Room
|