Post-operative Nausea and VomitingPhase 2PONVNCT05759481
Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
A Phase 2 study testing Hybrid anesthesia (propofol + sevoflurane) and Propofol only TIVA in people with Post-operative Nausea and Vomiting, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Nausea and Vomiting
- What is being tested?
- Hybrid anesthesia (propofol + sevoflurane) and Propofol only TIVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 12 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Undergoing general anesthesia for elective surgery
- Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
- No documented allergy/adverse reaction to propofol
- English speaking
- At least 18 years of age
Who cannot join
- Any anti-nausea medication taken within 24 hours prior to surgery
- Unable to provide consent independently
- Allergy or adverse reaction to propofol
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.
Read the detailed description
Propofol is administered as both low dose and as sole anesthetic in patients with history of PONV and/or motion sickness. But efficacy of one dose over the other is not studied. This study plans to clarify if propofol in low dose is as effective as its administration as sole anesthetic in patients with history of PONV and/or motion sickness
- Conditions
- Post-operative Nausea and Vomiting
- Being tested
- Hybrid anesthesia (propofol + sevoflurane), Propofol only TIVA
- Keywords
- Post-Operative Nausea, Post-Operative Vomiting, propofol, motion sickness
- Medical subject headings
- Vomiting, Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid anesthesia (propofol + sevoflurane)Drug
General anesthesia maintained with a continuous low-dose propofol infusion (25 mcg/kg/min) combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted.
Propofol only TIVADrug
General anesthesia maintained exclusively with intravenous propofol infusion, without the use of volatile anesthetics. Propofol dosing was titrated to maintain a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted
| Study group | Role | What they receive |
|---|---|---|
| Hybrid anesthesia (propofol + sevoflurane) | Active comparator | Participants received general anesthesia maintained with a continuous low-dose propofol infusion combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered. Receives: Drug: Hybrid anesthesia (propofol + sevoflurane) |
| Propofol only TIVA | Active comparator | Participants received general anesthesia maintained with propofol-based total intravenous anesthesia (TIVA). Propofol infusion was titrated to maintain a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered Receives: Drug: Propofol only TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV)
Postoperative nausea and vomiting (PONV) within 24 hours was defined as any episode of nausea, retching, or vomiting occurring from PACU discharge up to 24 hours after surgery. Data were collected using standardized patient questionnaires and follow-up telephone interviews conducted at 24 hours after surgery.
Measured: 24 hours
Secondary outcomes (2)
Episodes of Post Operative Nausea/Vomiting (PONV)
PONV in the post-anesthesia care unit (PACU) was defined as any episode of nausea, retching, or vomiting occurring between PACU admission and discharge. Events were documented by PACU nursing staff as part of routine postoperative care.
Measured: PACU
Use of Antiemetics
Use of rescue antiemetics was defined as administration of any antiemetic medication beyond standardized prophylaxis (dexamethasone and ondansetron), either during the post-anesthesia care unit (PACU) stay or within 24 hours after surgery. Antiemetic use was obtained from the medical record in the PACU and from patient self-report during standardized follow-up at 24 hours postoperatively. The outcome was analyzed as a categorical variable and reported as the number and percentage of participants requiring rescue antiemetics.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Feb 2024
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Revati Kanekar, Milton S. Hershey Medical Center
- Investigators
- Sonal Sharma, MD, Principal investigator, Assistant Professor, Department of Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759481
- Sponsor's protocol ID
- STUDY00021935
- Acronym
- PONV
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2023
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Keck WL, Deng E, Liu WM, Kanekar R, Lomivorotov V, Sharma S. Effect of low-dose propofol infusion with sevoflurane versus propofol-only total intravenous anesthesia on postoperative nausea and vomiting in high-risk patients: a single-blind randomized controlled clinical trial. BMC Anesthesiol. 2026 Jan 28;26(1):136. doi: 10.1186/s12871-026-03649-7.
PubMed 41593496
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
- ClinicalTrials.gov ID
- NCT05759481
- Acronym / sponsor ID
- PONV / STUDY00021935
- Conditions
- Post-operative Nausea and Vomiting
- Keywords
- Post-Operative Nausea, Post-Operative Vomiting, propofol, motion sickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Posted 14 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.
Detailed description
Propofol is administered as both low dose and as sole anesthetic in patients with history of PONV and/or motion sickness. But efficacy of one dose over the other is not studied. This study plans to clarify if propofol in low dose is as effective as its administration as sole anesthetic in patients with history of PONV and/or motion sickness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid anesthesia (propofol + sevoflurane) | Active comparator | Drug: Hybrid anesthesia (propofol + sevoflurane)Participants received general anesthesia maintained with a continuous low-dose propofol infusion combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered. |
| Propofol only TIVA | Active comparator | Drug: Propofol only TIVAParticipants received general anesthesia maintained with propofol-based total intravenous anesthesia (TIVA). Propofol infusion was titrated to maintain a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing general anesthesia for elective surgery
- Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
- No documented allergy/adverse reaction to propofol
- English speaking
- At least 18 years of age
Key exclusion criteria (4 listed)
- Any anti-nausea medication taken within 24 hours prior to surgery
- Unable to provide consent independently
- Allergy or adverse reaction to propofol
- Emergency surgery
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 |
|---|---|---|
| Hybrid anesthesia (propofol + sevoflurane)General anesthesia maintained with a continuous low-dose propofol infusion (25 mcg/kg/min) combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted. | Drug | Hybrid anesthesia (propofol + sevoflurane) |
| Propofol only TIVAGeneral anesthesia maintained exclusively with intravenous propofol infusion, without the use of volatile anesthetics. Propofol dosing was titrated to maintain a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted | Drug | Propofol only TIVA |
Primary outcome
Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV)
Time frame: 24 hours
Postoperative nausea and vomiting (PONV) within 24 hours was defined as any episode of nausea, retching, or vomiting occurring from PACU discharge up to 24 hours after surgery. Data were collected using standardized patient questionnaires and follow-up telephone interviews conducted at 24 hours after surgery.
2 secondary outcomes
Episodes of Post Operative Nausea/Vomiting (PONV)
Time frame: PACU
Use of Antiemetics
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41593496Keck WL, Deng E, Liu WM, Kanekar R, Lomivorotov V, Sharma S. Effect of low-dose propofol infusion with sevoflurane versus propofol-only total intravenous anesthesia on postoperative nausea and vomiting in high-risk patients: a single-blind randomized controlled clinical trial. BMC Anesthesiol. 2026 Jan 28;26(1):136. doi: 10.1186/s12871-026-03649-7.
Related trials for Post-operative 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.
Sonal Sharma, MD principal investigator
Assistant Professor, Department of Anesthesiology and Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hybrid anesthesia (propofol + sevoflurane) and Propofol only TIVA in people with Post-operative Nausea and Vomiting, run by Milton S. Hershey 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 5 inclusion and 4 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 14 Aug 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV) (time frame: 24 hours). 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 NCT05759481, 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 14 Aug 2026.