A Phase 2 interventional study of Hybrid anesthesia (propofol + sevoflurane) and Propofol only TIVA in Post-operative Nausea and Vomiting, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment
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.
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
793 studies on the registry are indexed under Vomiting; 99 are open to participants now.
This study's enrollment of 65 is below the median of 103 across 673 interventional studies indexed under Vomiting.
Browse Vomiting studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Hybrid anesthesia (propofol + sevoflurane)
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
Drug: Propofol only TIVA
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.
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
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.
Time frame: 24 hours
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.
Time frame: 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.
Time frame: 24 hours
Number of Subjects Experiencing Nausea.
The number of subjects self-reported nausea episodes.
Time frame: PACU upto 23 hrs.
Number of Subjects Experiencing Retching.
Number of self-reported retching episodes (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents)
Time frame: PACU upto 23 hrs
Vomiting (Forceful Expulsion of Gastric Contents) Episodes
Number of self-reported vomiting episodes
Time frame: 24 hours
Number of Subjects Receiving Medication for Nausea.
Number of subjects who received Ondansetron medication for treating nausea.
Time frame: PACU upto 1 hrs
Number of Subjects Receiving Medication for Nausea - Promethazine
Number of subjects receiving promethazine for nausea treatment.
Time frame: PACU upto 1 hrs.
Number of Subjects Receiving Medication for Nausea.- Promethazine.
Number of subjects receiving promethazine medication for nausea.
Time frame: 24 hours.
Number of Subjects Who Received Prochlorperazine
medication administered
Time frame: PACU upto 1 hr
Number of Subjects Receiving Medication for Nausea - Prochlorperazine
Number of subjects receiving medication for nausea - prochlopreazine.
Time frame: 24 hours
Number of Subjects Receiving Droperidol
medication administered
Time frame: PACU upto 1 hr
Number of Subject Receiving Scopolamine Patch
medication administered
Time frame: 24 hours
Number of Subjects Experiencing Nausea (Urge to Vomit Episodes)
Number of subjects experiencing nausea.
Time frame: 24 hours
Number of Subjects Experiencing Retching Contents)
Number of subjects who experienced retching and self-reported it. (labored, spasmodic, rhythmic contractions of respiratory scales without expulsion of gastric episodes
Time frame: 24 hours
Number of Subjected Experiencing Vomiting (Forceful Expulsion of Gastric Contents) Episodes
Number of subjects experiencing vomiting (forceful expulsion of gastric contents)
Time frame: 24 hours
Number of Subjects Receiving Ondansetron
Number of subjects receiving ondansetron.
Time frame: 24 hours
Participants were recruited between February 2024 and March 2025 at a single academic tertiary-care center (Penn State Health Milton S. Hershey Medical Center). Recruitment occurred in the preoperative surgical setting for adult patients scheduled for elective laparoscopic surgery under general anesthesia, including general, gynecologic, and urologic procedures.
| Milestone | Hybrid Group | Propofol TIVA |
|---|---|---|
| Started | 32 | 33 |
| Completed | 32 | 31 |
| Not completed | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 |
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.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV) | 19 | 14 |
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.
| episodes | Hybrid Group | Propofol TIVA |
|---|---|---|
| Episodes of Post Operative Nausea/Vomiting (PONV) | 9 | 7 |
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.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Use of Antiemetics | 9 | 7 |
The number of subjects self-reported nausea episodes.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Experiencing Nausea. | 9 | 7 |
Number of self-reported retching episodes (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents)
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Experiencing Retching. | 0 | 0 |
Number of self-reported vomiting episodes
Results for this outcome have not been posted.
Number of subjects who received Ondansetron medication for treating nausea.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Receiving Medication for Nausea. | 4 | 5 |
Number of subjects receiving promethazine for nausea treatment.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Receiving Medication for Nausea - Promethazine | 5 | 2 |
Number of subjects receiving promethazine medication for nausea.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Receiving Medication for Nausea.- Promethazine. | 6 | 3 |
medication administered
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Who Received Prochlorperazine | 1 | 1 |
Number of subjects receiving medication for nausea - prochlopreazine.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Receiving Medication for Nausea - Prochlorperazine | 1 | 4 |
medication administered
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Receiving Droperidol | 0 | 1 |
medication administered
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subject Receiving Scopolamine Patch | 2 | 0 |
Number of subjects experiencing nausea.
| participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Experiencing Nausea (Urge to Vomit Episodes) | 30 | 50 |
Number of subjects who experienced retching and self-reported it. (labored, spasmodic, rhythmic contractions of respiratory scales without expulsion of gastric episodes
| participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Experiencing Retching Contents) | 3 | 8 |
Number of subjects experiencing vomiting (forceful expulsion of gastric contents)
| participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjected Experiencing Vomiting (Forceful Expulsion of Gastric Contents) Episodes | 6 | 19 |
Number of subjects receiving ondansetron.
| Participants | Hybrid Group | Propofol TIVA |
|---|---|---|
| Number of Subjects Receiving Ondansetron | 7 | 6 |
Collected over Adverse event data were collected from the time of anesthesia induction through 24 hours after surgery, including events occurring in the post-anesthesia care unit and those reported during standardized 24-hour postoperative follow-up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hybrid Group | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Propofol TIVA | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
A small number of participants were enrolled and randomized but excluded from the final analysis because postoperative follow-up data could not be obtained. Despite attempted telephone follow-up at 24 hours and a second attempt at 48 hours, these participants did not respond, resulting in incomplete outcome data. Per protocol, participants with missing follow-up data were excluded from analysis.
| Age, Continuous(years) | Hybrid Group | Propofol TIVA | Total |
|---|---|---|---|
| Mean | 40.5 (28.5 to 59) | 40 (36 to 55) | 40.25 (28.5 to 59) |
| Sex: Female, Male(Participants) | Hybrid Group | Propofol TIVA | Total |
|---|---|---|---|
| Female | 27 | 30 | 57 |
| Male | 5 | 3 | 8 |
| Race and Ethnicity Not Collected(Participants) | Hybrid Group | Propofol TIVA | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body Mass Index (BMI, kg/m²)(kg/m²) | Hybrid Group | Propofol TIVA | Total |
|---|---|---|---|
| Median | 29.5 (24.5 to 37.5) | 29 (25 to 31) | 29.25 (25 to 33) |
| Number of smokers(Participants) | Hybrid Group | Propofol TIVA | Total |
|---|---|---|---|
| Count of participants | 2 | 1 | 3 |
| ASA physical status(Participants) | Hybrid Group | Propofol TIVA | Total |
|---|---|---|---|
| ASA I | 0 | 1 | 1 |
| ASA II | 19 | 26 | 45 |
| ASA III | 13 | 6 | 19 |
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