Menstrual Cycle and Postanesthetic Shivering

NCT06996977 | Not Yet Recruiting

• 1 other identifier: menstrual cycle
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Shivering

Keywords

menstrual cycle; core temperature

Outcome Measures

Primary Outcomes (2)

• 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.

  First 15 minutes after surgery

• Number of patients who require meperidine

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

  first 15 minutes after surgery

Secondary Outcomes (2)

• 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

Study Arms (2)

Group follicular

Follicular phase of menstrual cycle

Group luteal

Luteal phase of menstrual cycle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients scheduled for elective nose surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir City Hospital

Izmir, Bayraklı, 35540, Turkey (Türkiye)

Location

Related Publications (3)

• Simegn GD, Bayable SD, Fetene MB. Prevention and management of perioperative hypothermia in adult elective surgical patients: A systematic review. Ann Med Surg (Lond). 2021 Nov 14;72:103059. doi: 10.1016/j.amsu.2021.103059. eCollection 2021 Dec.

  PMID: 34840773 BACKGROUND

• Tatsumi T, Sampei M, Saito K, Honda Y, Okazaki Y, Arata N, Narumi K, Morisaki N, Ishikawa T, Narumi S. Age-Dependent and Seasonal Changes in Menstrual Cycle Length and Body Temperature Based on Big Data. Obstet Gynecol. 2020 Oct;136(4):666-674. doi: 10.1097/AOG.0000000000003910.

  PMID: 32925608 BACKGROUND

• 1. V. Erden, C. Güler, H. Bulut, N. Özsoy Toprak, and N. Uslu, "Menstrual cycle phase may effect the thermoregulation during anesthesia," International Journal of Anesthesia, vol. 5, 2018.

  BACKGROUND

Study Officials

• Halide Hande ŞAHİNKAYA, MD

  Izmir City Hospital

  PRINCIPAL INVESTIGATOR

• Gözde GÜRSOY ÇİRKİNOĞLU, MD

  Izmir City Hospital

  STUDY CHAIR

• Tuba KUVVET YOLDAŞ, MD

  Izmir City Hospital

  STUDY CHAIR

• Volkan HANCI, MD

  9 Eylul University Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Halide Hande Şahinkaya, MD

CONTACT

+905058892157; drhhande@yahoo.com

Gözde Gürsoy Çirkinoğlu, MD

CONTACT

+905544071757; dr.gozde.gursoy@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 30, 2025
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 15, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

TU (1)