Menstrual Cycle and Postanesthetic Shivering
ConditionPostoperative Shivering
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorBozyaka Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients undergoing elective open technical septoplasty or rhinoplasty
18-45 years of age
ASA score I-II
Disqualifiers
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
Trial population
Female patients scheduled for elective nose surgery
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Group follicular
Group B: Group luteal
Trial outcomes
Primary outcomes
1
Postoperative Shivering
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 surgery2
Number of patients who require meperidine
The need for intravenous meperidine administration when the postanesthetic shivering scale (PAS) of the patient is above 3.
Time frame
first 15 minutes after surgerySecondary outcomes
1
Number of patients whose core body temperature is below 36 °C
Intraoperative hypothermia is defined as a core body temperature below 36°C under anesthesia.
Time frame
perioperative2
The time when intraoperative core body temperature is detected below 36 °C
The time when the core body temperature is below 36°C during general anesthesia.
Time frame
perioperativeSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: