Izmir City Hospital
Izmir, Bayraklı, 35540, Turkey (Türkiye)
NCT Number: NCT06996977
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Observational
Izmir, Bayraklı, 35540, Turkey (Türkiye)
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;
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: First 15 minutes after surgery
Postanesthetic shivering will be evaluated in the postanesthesia care unit by Postanesthetic Shivering Scale. The scale is a 5-points scale. 0= no shivering
1= no visible muscle activity but piloerection, peripheral vasoconstriction, or both are present (other causes excluded); 2 = muscular activity in only one muscle group; 3 = moderate muscular activity in more than one muscle group but no generalized shaking; 4 = violent muscular activity that involves the whole body. 3 and 4 mean worse outcome as the patient needs medication to treat shivering.
Time frame: first 15 minutes after surgery
The need for intravenous meperidine administration when the postanesthetic shivering scale (PAS) of the patient is above 3.
Time frame: perioperative
Intraoperative hypothermia is defined as a core body temperature below 36°C under anesthesia.
Time frame: perioperative
The time when the core body temperature is below 36°C during general anesthesia.
Trial opening soon.
Get NotifiedBozyaka Training and Research Hospital
Other
The Effect of Menstrual Cycle on Postanesthetic Shivering; Prospective Observational Study
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