Menstrual Cycle and Postanesthetic Shivering

Bozyaka Training and Research Hospital

Status

Not yet enrolling

Conditions

Postoperative Shivering

Study type

Observational

Funder types

Other

Identifiers

NCT06996977

menstrual cycle

Details and patient eligibility

About

The goal of this observational study is to learn about the effect of menstrual cycle on postoperative shivering in women of fertile age. The main question it aims to answer is:

Do women in the luteal phase have less postoperative shivering? Participants will have their intraoperative body temperature recorded and will be observed for postanesthetic shivering, depending on whether they are in the luteal phase or follicular phase.

Full description

Postoperative shivering is a protective mechanism that the body uses to raise body temperature by rhythmic muscle contractions during hypothermia. Peroperative hypothermia is the most important cause of shivering after recovery. Shivering not only causes a decrease in patient comfort and discomfort but also increases metabolic demand by increasing oxygen consumption. This is an undesirable situation.

Women's hormonal status affects body temperature control. During the luteal phase, progesterone levels increase and this results in a 0.4 °C increase in core body temperature. The threshold for vasodilation also increases during this phase. Therefore, thermoregulation also changes during the luteal phase. Core body temperature in the follicular and luteal phase does not change with exposure to cold. However, under general anesthesia, core temperature is significantly reduced in both the luteal and follicular phase. Thermoregulatory vasoconstriction is less inhibited during luteal phase anesthesia.

The primary aim of our study was to determine the relationship between different phases of the menstrual cycle and the frequency of postoperative shivering. The secondary aim was to evaluate the incidence of intraoperative hypothermia and the duration of onset of intraoperative hypothermia in different phases of the menstrual cycle.

The study is planned as a prospective cross-sectional observational study. Female patients aged 18-45 years with ASA (American Society of Anesthesiology) score I-II who will undergo elective surgery for open technique septoplasty or rhinoplasty will be included in the study. They will be recorded in two groups as follicular group (F) and luteal group (L).

Patients data will be recorded;

Demographic data
Primary disease
Comorbidities
American Society of Anesthesiologists (ASA) Physical Status Classification
The phase of the menstrual cycle (luteal or follicular phase) according to the patient's medical history
Core body temperatures will be noted in the preoperative waiting area, before induction of general anesthesia, 1st hour under general anesthesia, 2nd hour under general anesthesia, 3rd hour under general anesthesia and in the postanesthetic recovery unit.
Anesthesia and duration of surgery
Infusion fluid quantity
Pain level in the postoperative recovery unit (numerical rating scale-NRS)
Postoperative tremors
PAS (postanesthetic shivering scale) value SPSS statistical program for Windows will be used for statistical analysis of the results. Considering the number of surgeries performed in previous periods, it was predicted that approximately 100 patients could be included in the study within this period. This period, which was determined to ensure homogeneous distribution of the groups, will be extended if necessary and more patients will be included in the study. Parametric descriptive values will be given as mean and standard deviation, and non-parametric values will be given as n (%) and median and IQR (interquartile range). The conformity of the data to normal distribution will be evaluated by one sample Kolmogorov-Smirnov test. Comparisons of quantitative data conforming to normal distribution will be made with Student T test and comparisons of data not conforming to normal distribution will be made with Mann Whitney U test. Chi-Square test will be used to compare qualitative data. For the analyses, the significance level will be accepted as p<0.05 at 95% confidence interval.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients undergoing elective open technical septoplasty or rhinoplasty
18-45 years of age
ASA score I-II

Exclusion criteria

Patient-legal representative does not want to be included in the study
Emergency surgery
Use of drugs that affect cardiovascular function, heat balance and hormone levels (e.g. combined oral contraceptives)
Menstrual irregularity
Polycystic ovary syndrome
Thyroid disease
Autonomic disease
Reyno disease
Uncontrolled diabetes mellitus
Uncontrolled hypertension
Surgeries where the duration of anesthesia is less than 1 hour
Patients with NRS pain score above 7 in the recovery unit after anesthesia
Core body temperature below 36°C before induction of general anesthesia