Postoperative Nausea and VomitingNCT07242209
Sugammadex and Menstrual Cycle in Postoperative Nausea and Vomiting
An observational study of Postoperative Nausea and Vomiting and Menstrual Cycle, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting, Menstrual Cycle
- What is being tested?
- PONV Assessment Questionnaire
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2025to 15 May 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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
Who cannot join
- Irregular menstrual cycle
- Unknown date of last menstrual period
- Receiving estrogen and/or progesterone supplementation
- Pre-menopausal or menopausal status
- Pregnant
- Breastfeeding
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University-Anesthesiology and Reanimation Department
Sakarya, Serdivan, 54050
About this study
Official title: The Relationship Between Menstrual Cycle Phases and Postoperative Nausea and Vomiting: The Role of Sugammadex
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.
Read the detailed description
This clinical trial aims to evaluate the effect of menstrual cycle phases on the incidence of postoperative nausea and vomiting (PONV) in women of reproductive age undergoing septorhinoplasty under general anesthesia. PONV is a common postoperative complication that can negatively impact patient recovery, prolong discharge time from the post-anesthesia care unit, and decrease overall patient satisfaction. Several risk factors for PONV have been identified, and recent consensus guidelines published in 2020 have also suggested that the menstrual cycle may influence PONV risk.
In this prospective observentional study, participants will be randomly assigned to receive either preoperative nebulized lidocaine or nebulized 3% sodium chloride solution, administered 15 minutes before surgery. The primary objective is to determine whether menstrual cycle phase (follicular, ovulatory, or luteal) is associated with differences in PONV incidence. The secondary objective is to evaluate whether the use of sugammadex during anesthesia has an additional effect on PONV occurrence across different menstrual phases.
Sugammadex, a modified γ-cyclodextrin that selectively binds aminosteroidal neuromuscular blocking agents such as rocuronium, may also interact with endogenous steroid hormones. Pharmacokinetic studies have shown that sugammadex exposure can decrease progesterone levels by approximately 34% and may reduce estrogen levels as well. Given the hormonal fluctuations during the menstrual cycle, understanding these interactions may help identify specific phases associated with increased PONV risk and support the development of individualized anesthesia management strategies.
All participants will receive standard anesthetic and surgical care. PONV assessment will be performed in the postoperative care unit and during the first 24 hours after surgery. Demographic data, anesthetic drug information, menstrual cycle phase, and PONV outcomes will be recorded and statistically analyzed.
The results of this trial may contribute to improved understanding of the interaction between hormonal status, anesthetic drugs, and postoperative outcomes, potentially informing future preventive measures for PONV in women undergoing elective surgery.
- Conditions
- Postoperative Nausea and Vomiting, Menstrual Cycle
- Being tested
- PONV Assessment Questionnaire
- Keywords
- postoperative nausea and vomiting, menstruel cycle, septorhinoplasty, sugammadex, female reproductive age
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PONV Assessment QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Follicular | Women in the follicular phase of their menstrual cycle undergoing septorhinoplasty. Receives: Other: PONV Assessment Questionnaire | |
| Group ovulatory | Women in the ovulatory phase of their menstrual cycle undergoing septorhinoplasty. Receives: Other: PONV Assessment Questionnaire | |
| Group Luteal | Women in the luteal phase of their menstrual cycle undergoing septorhinoplasty. Receives: Other: PONV Assessment Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after surgery
Secondary outcomes (2)
Relationship Between Sugammadex Use and Postoperative Nausea and Vomiting (PONV)
This outcome evaluates whether the use of sugammadex during anesthesia is associated with the incidence of postoperative nausea and vomiting (PONV) in women undergoing septorhinoplasty. Anesthetic records will be reviewed to determine sugammadex administration and dosage. PONV incidence within the first 24 hours postoperatively will be compared between patients who received sugammadex and those who did not.
Measured: 24 hours after surgery
Relationship Between Sugammadex Use and Menstrual Cycle Phase
This outcome evaluates whether sugammadex administration during anesthesia is associated with the menstrual cycle phase in women undergoing septorhinoplasty. Anesthetic records will be reviewed to determine sugammadex use, and menstrual cycle phase (follicular, ovulatory, luteal) will be recorded. The analysis aims to explore potential interactions between sugammadex exposure and hormonal variations across the menstrual cycle.
Measured: During anesthesia administration in surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start18 Dec 2025
- Primary completion9 Mar 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Alaçam, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242209
- Sponsor's protocol ID
- E-43012747-050.04-513202-482
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share individual participant data. Data will be collected and analyzed solely for research purposes and will remain confidential in accordance with institutional and ethical guidelines.
Publications
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.
PubMed 15467297
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Menstrual Cycle Phases and Postoperative Nausea and Vomiting: The Role of Sugammadex
- ClinicalTrials.gov ID
- NCT07242209
- Acronym / sponsor ID
- E-43012747-050.04-513202-482
- Conditions
- Postoperative Nausea and Vomiting, Menstrual Cycle
- Keywords
- postoperative nausea and vomiting, menstruel cycle, septorhinoplasty, sugammadex, female reproductive age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial aims to evaluate the effect of menstrual cycle phases on the incidence of postoperative nausea and vomiting (PONV) in women of reproductive age undergoing septorhinoplasty under general anesthesia. PONV is a common postoperative complication that can negatively impact patient recovery, prolong discharge time from the post-anesthesia care unit, and decrease overall patient satisfaction. Several risk factors for PONV have been identified, and recent consensus guidelines published in 2020 have also suggested that the menstrual cycle may influence PONV risk.
In this prospective observentional study, participants will be randomly assigned to receive either preoperative nebulized lidocaine or nebulized 3% sodium chloride solution, administered 15 minutes before surgery. The primary objective is to determine whether menstrual cycle phase (follicular, ovulatory, or luteal) is associated with differences in PONV incidence. The secondary objective is to evaluate whether the use of sugammadex during anesthesia has an additional effect on PONV occurrence across different menstrual phases.
Sugammadex, a modified γ-cyclodextrin that selectively binds aminosteroidal neuromuscular blocking agents such as rocuronium, may also interact with endogenous steroid hormones. Pharmacokinetic studies have shown that sugammadex exposure can decrease progesterone levels by approximately 34% and may reduce estrogen levels as well. Given the hormonal fluctuations during the menstrual cycle, understanding these interactions may help identify specific phases associated with increased PONV risk and support the development of individualized anesthesia management strategies.
All participants will receive standard anesthetic and surgical care. PONV assessment will be performed in the postoperative care unit and during the first 24 hours after surgery. Demographic data, anesthetic drug information, menstrual cycle phase, and PONV outcomes will be recorded and statistically analyzed.
The results of this trial may contribute to improved understanding of the interaction between hormonal status, anesthetic drugs, and postoperative outcomes, potentially informing future preventive measures for PONV in women undergoing elective surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Follicular | – | Other: PONV Assessment QuestionnaireWomen in the follicular phase of their menstrual cycle undergoing septorhinoplasty. |
| Group ovulatory | – | Other: PONV Assessment QuestionnaireWomen in the ovulatory phase of their menstrual cycle undergoing septorhinoplasty. |
| Group Luteal | – | Other: PONV Assessment QuestionnaireWomen in the luteal phase of their menstrual cycle undergoing septorhinoplasty. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Irregular menstrual cycle
- Unknown date of last menstrual period
- Receiving estrogen and/or progesterone supplementation
- Pre-menopausal or menopausal status
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PONV Assessment QuestionnaireAll 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. | Other | Group Follicular, Group Luteal, Group ovulatory |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: Within 24 hours after surgery
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.
2 secondary outcomes
Relationship Between Sugammadex Use and Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hours after surgery
Relationship Between Sugammadex Use and Menstrual Cycle Phase
Time frame: During anesthesia administration in surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Results publication: PubMed 15467297Sener 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.
- Individual participant dataSharing planned: No. This study will not share individual participant data. Data will be collected and analyzed solely for research purposes and will remain confidential in accordance with institutional and ethical guidelines.
Related trials for Postoperative Nausea and Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting and Menstrual Cycle, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07242209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.