Postoperative Nausea and VomitingNCT06816355
Exogenous Sex Hormones and PONV
An observational study of Postoperative Nausea and Vomiting and Sex Hormone, run by Riverside University Health System Medical Center at 1 site in United States.
Trial summary
This study aims to investigate the rates of postoperative nausea and vomiting in transgender patients on hormone therapy compared to cisgender patients undergoing the same procedures (hysterectomy, orchiectomy, augmentation mammoplasty). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Sex Hormone, Transgender
- What is being tested?
- Orchiectomy, Hysterectomy and Augmentation mammoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 7,348 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 4 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing orchiectomies, hysterectomies, or augmentation mammoplasties.
Who may be able to join
- Patients who underwent hysterectomies.
- administered testosterone within 6 months and 1 day before their hysterectomy
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.
- Cisgender Female Group
- identified as female.
- patients underwent an orchiectomy.
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- administered estrogen within 6 months and 1 day before their orchiectomy
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.
- Cisgender Male Group
- identified as male.
- underwent augmentation mammoplasties.
- administered estrogen within 6 months and 1 day before their augmentation mammoplasty
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorder, or transsexualism.
- Cisgender Female Group
- Identified as female
Who cannot join
- Patients who had malignant neoplasm of the uterus, ovarian, cervical, endometrium, or adnexa.
- Transgender Male Group
- administered testosterone within 6 months and 1 day before their hysterectomy
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.
- Orchiectomy Cohort:
- history of malignant neoplasm of the testis, malignant neoplasm of the prostate, Fournier gangrene, or vascular disorders of male genital organs
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- Transgender Female Group
- administered estrogen within 6 months and 1 day before their orchiectomy
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.
- Augmentation Mammoplasty:
- Have diagnosis of malignant neoplasm of the breast .
- Transgender Female Group
- administered estrogen within 6 months and 1 day before their hysterectomy
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riverside University Health System Medical Center
Moreno Valley, California, 92555
About this study
Official title: Exogenous Sex Hormones and PONV: Evaluating Postoperative Nausea and Vomiting Risk in Transgender Patients
This study aims to investigate the rates of postoperative nausea and vomiting in transgender patients on hormone therapy compared to cisgender patients undergoing the same procedures (hysterectomy, orchiectomy, augmentation mammoplasty).
Read the detailed description
A retrospective cohort study will be performed using the TriNetX database. Cohorts were defined using Common Procedural Terminology and International Classification of Diseases-10 codes. Separate analyses will be performed for hysterectomies, orchiectomies, and augmentation mammoplasties. Patients will be excluded if they had a history of postoperative nausea and vomiting or a history of neoplasm for which the respective procedure would be indicated (e.g., uterine, cervical, testicular, or breast cancer). Transgender patients will be excluded if not on exogenous hormone therapy and cisgender patients will be excluded if on the same exogenous hormone therapy as their transgender counterparts. Patients will be divided into two groups (transgender group and cisgender group) based on whether they had a diagnosis of sex reassignment, transsexualism, or gender identity disorder. The cohorts will be propensity score-matched based on age, race/ethnicity, and tobacco use.
- Conditions
- Postoperative Nausea and Vomiting, Sex Hormone, Transgender
- Being tested
- Orchiectomy, Hysterectomy, Augmentation mammoplasty
- Keywords
- Postoperative nausea and vomiting, sex hormone, estrogen, testosterone, transgender
- 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.
OrchiectomyProcedure or surgery
CPT:54520
HysterectomyProcedure or surgery
CPT:1013911
Augmentation mammoplastyProcedure or surgery
CPT:19325
| Study group | Role | What they receive |
|---|---|---|
| Transgender male | Not described Receives: Procedure: Hysterectomy | |
| Transgender female | Not described Receives: Procedure: Orchiectomy; Procedure: Augmentation mammoplasty | |
| Cisgender male | Not described Receives: Procedure: Orchiectomy | |
| Cisgender female | Not described Receives: Procedure: Hysterectomy; Procedure: Augmentation mammoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue antiemetics
The primary outcome will be the administration of a rescue antiemetic within 24 hours of surgery. Rescue antiemetics will include droperidol, promethazine, dimenhydrinate, metoclopramide, and prochlorperazine based on rescue antiemetics from the Fourth Consensus PONV Guidelines.
Measured: Within 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start4 Feb 2025
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
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.
- 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
- Retrospective
- Enrolment
- 7,348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverside University Health System Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Baker, Riverside University Health System Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816355
- Sponsor's protocol ID
- PONV
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A plan to share IPD is not in place at this time.
Publications
Soloniuk LJ, Sran J, Baker C, Kim A, Han B, Canumay S, Novak D, Sinha AC, Stier G. Exogenous Sex Hormones and Postoperative Nausea and Vomiting Risk in Transgender Patients. Anesth Analg. 2026 Sep 1;143(3):485-492. doi: 10.1213/ANE.0000000000007929. Epub 2026 Feb 2.
PubMed 41628415
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exogenous Sex Hormones and PONV: Evaluating Postoperative Nausea and Vomiting Risk in Transgender Patients
- ClinicalTrials.gov ID
- NCT06816355
- Acronym / sponsor ID
- PONV
- Conditions
- Postoperative Nausea and Vomiting, Sex Hormone, Transgender
- Keywords
- Postoperative nausea and vomiting, sex hormone, estrogen, testosterone, transgender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,348 participants (actual)
- Lead sponsor
- Riverside University Health System Medical CenterUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 10 Feb 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 study aims to investigate the rates of postoperative nausea and vomiting in transgender patients on hormone therapy compared to cisgender patients undergoing the same procedures (hysterectomy, orchiectomy, augmentation mammoplasty).
Detailed description
A retrospective cohort study will be performed using the TriNetX database. Cohorts were defined using Common Procedural Terminology and International Classification of Diseases-10 codes. Separate analyses will be performed for hysterectomies, orchiectomies, and augmentation mammoplasties. Patients will be excluded if they had a history of postoperative nausea and vomiting or a history of neoplasm for which the respective procedure would be indicated (e.g., uterine, cervical, testicular, or breast cancer). Transgender patients will be excluded if not on exogenous hormone therapy and cisgender patients will be excluded if on the same exogenous hormone therapy as their transgender counterparts. Patients will be divided into two groups (transgender group and cisgender group) based on whether they had a diagnosis of sex reassignment, transsexualism, or gender identity disorder. The cohorts will be propensity score-matched based on age, race/ethnicity, and tobacco use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transgender male | – | Procedure: Hysterectomy |
| Transgender female | – | Procedure: Orchiectomy, Procedure: Augmentation mammoplasty |
| Cisgender male | – | Procedure: Orchiectomy |
| Cisgender female | – | Procedure: Hysterectomy, Procedure: Augmentation mammoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing orchiectomies, hysterectomies, or augmentation mammoplasties.
Key inclusion criteria (15 listed)
- Patients who underwent hysterectomies.
- administered testosterone within 6 months and 1 day before their hysterectomy
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.
- Cisgender Female Group
- identified as female.
Key exclusion criteria (14 listed)
- Patients who had malignant neoplasm of the uterus, ovarian, cervical, endometrium, or adnexa.
- Transgender Male Group
- administered testosterone within 6 months and 1 day before their hysterectomy
- have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.
- history of malignant neoplasm of the testis, malignant neoplasm of the prostate, Fournier gangrene, or vascular disorders of male genital organs
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 |
|---|---|---|
| OrchiectomyCPT:54520 | Procedure or surgery | Cisgender male, Transgender female |
| HysterectomyCPT:1013911 | Procedure or surgery | Cisgender female, Transgender male |
| Augmentation mammoplastyCPT:19325 | Procedure or surgery | Cisgender female, Transgender female |
Primary outcome
Rescue antiemetics
Time frame: Within 24 hours of surgery
The primary outcome will be the administration of a rescue antiemetic within 24 hours of surgery. Rescue antiemetics will include droperidol, promethazine, dimenhydrinate, metoclopramide, and prochlorperazine based on rescue antiemetics from the Fourth Consensus PONV Guidelines.
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 21 Feb 2025.
- Derived from this study: PubMed 41628415Soloniuk LJ, Sran J, Baker C, Kim A, Han B, Canumay S, Novak D, Sinha AC, Stier G. Exogenous Sex Hormones and Postoperative Nausea and Vomiting Risk in Transgender Patients. Anesth Analg. 2026 Sep 1;143(3):485-492. doi: 10.1213/ANE.0000000000007929. Epub 2026 Feb 2.
- Individual participant dataSharing planned: No. A plan to share IPD is not in place at this time.
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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 Sex Hormone, run by Riverside University Health System Medical Center at 1 site in United States.
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 15 inclusion and 14 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 21 Feb 2025. 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 United States. 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?
Rescue antiemetics (time frame: Within 24 hours of 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 NCT06816355, 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 21 Feb 2025.