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临床试验/NCT06996977
NCT06996977尚未招募不适用

The Effect of Menstrual Cycle on Postanesthetic Shivering; Prospective Observational Study

Bozyaka Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Postoperative Shivering

研究概览

简要总结

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.

详细描述

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;

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Postoperative Shivering

时间窗: 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.

Number of patients who require meperidine

时间窗: first 15 minutes after surgery

The need for intravenous meperidine administration when the postanesthetic shivering scale (PAS) of the patient is above 3.

次要结局

  • Number of patients whose core body temperature is below 36 °C(perioperative)
  • The time when intraoperative core body temperature is detected below 36 °C(perioperative)

研究者

发起方
Bozyaka Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Halide Hande Şahinkaya

Principal Investigator

Bozyaka Training and Research Hospital

研究点 (1)

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