Sugammadex and Menstrual Cycle in Postoperative Nausea and Vomiting

NCT07242209 | Recruiting

• 1 other identifier: E-43012747-050.04-513202-482
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate the relationship between menstrual cycle phases and the incidence of postoperative nausea and vomiting (PONV) in women of reproductive age undergoing septorhinoplasty surgery. The study's primary objective is to determine whether different phases of the menstrual cycle are associated with variations in PONV frequency. As a secondary objective, the relationship between menstrual phases, PONV incidence, and the use of sugammadex during anesthesia will be analyzed. No additional intervention will be applied beyond routine clinical practice; all data will be collected prospectively from anesthesia records and postoperative evaluations.

Conditions

Postoperative Nausea and Vomiting; Menstrual Cycle

Keywords

postoperative nausea and vomiting; menstruel cycle; septorhinoplasty; sugammadex; female reproductive age

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting

  The primary outcome of this study is the incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after septorhinoplasty surgery. PONV will be evaluated using a standardized questionnaire administered during the postoperative recovery period and at 24 hours post-surgery. The presence, frequency, and severity of nausea and vomiting will be recorded. Data will be analyzed according to the menstrual cycle phase (follicular, ovulatory, luteal) to determine possible associations between menstrual phase and PONV occurrence.

  Within 24 hours after surgery

Secondary Outcomes (2)

• Relationship Between Sugammadex Use and Postoperative Nausea and Vomiting (PONV)

  24 hours after surgery

• Relationship Between Sugammadex Use and Menstrual Cycle Phase

  During anesthesia administration in surgery

Study Arms (3)

Group Follicular

Women in the follicular phase of their menstrual cycle undergoing septorhinoplasty.

Other: PONV Assessment Questionnaire

Group ovulatory

Women in the ovulatory phase of their menstrual cycle undergoing septorhinoplasty.

Other: PONV Assessment Questionnaire

Group Luteal

Women in the luteal phase of their menstrual cycle undergoing septorhinoplasty.

Other: PONV Assessment Questionnaire

Interventions

PONV Assessment Questionnaire OTHER

All participants will complete a standardized postoperative questionnaire designed to assess the presence, frequency, and severity of nausea and vomiting within the first 24 hours after septorhinoplasty surgery. The questionnaire will be administered in the post-anesthesia care unit and during the postoperative follow-up period. Responses will be recorded by trained research staff or anesthesia team members. No experimental drug or additional therapeutic intervention will be applied. The collected data will be used to evaluate possible associations between postoperative nausea and vomiting (PONV) incidence and the menstrual cycle phase (follicular, ovulatory, or luteal). In addition, anesthetic records will be reviewed to document the use of routinely administered perioperative agents, including sugammadex, to assess their potential influence on PONV outcomes.

Group Follicular; Group Luteal; Group ovulatory

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women of reproductive age (18-40 years) who are scheduled to undergo septorhinoplasty surgery under general anesthesia. Eligible participants have a regular menstrual cycle and are classified as ASA physical status I or II. Participants with irregular menstrual cycles, unknown last menstrual period, pre-menopausal or menopausal status, or those receiving hormonal supplementation are excluded. Other exclusion criteria include pregnancy, breastfeeding, ASA III-IV status, high risk for postoperative nausea and vomiting (Apfel score ≥3), history of drug allergy, and surgery duration exceeding 3 hours. Data will be collected prospectively from anesthesia records, postoperative assessments, and standardized questionnaires evaluating postoperative nausea and vomiting (PONV).

You may qualify if:

• Female sex
• Age between 18 and 40 years
• Regular menstrual cycle
• Scheduled for ENT (ear, nose, and throat) surgery
• Classified as ASA physical status I or II

You may not qualify if:

• Irregular menstrual cycle
• Unknown date of last menstrual period
• Receiving estrogen and/or progesterone supplementation
• Pre-menopausal or menopausal status
• Pregnant
• Breastfeeding
• Classified as ASA physical status III or IV
• Apfel score ≥ 3
• History of drug allergy
• Surgery duration exceeding 3 hours
• Age \<18 or \>40 years

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University-Anesthesiology and Reanimation Department

Sakarya, Serdivan, 54050, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Sener EB, Kocamanoglu S, Cetinkaya MB, Ustun E, Bildik E, Tur A. Effects of menstrual cycle on postoperative analgesic requirements, agitation, incidence of nausea and vomiting after gynecological laparoscopy. Gynecol Obstet Invest. 2005;59(1):49-53. doi: 10.1159/000081222. Epub 2004 Sep 30.

  PMID: 15467297 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: December 18, 2025
• Primary Completion: March 9, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)