Post-operative Nausea and Vomiting
Conditions
Keywords
Post-Operative Nausea, Post-Operative Vomiting, propofol, motion sickness
Brief 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.
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
Interventions
DRUGHybrid 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.
DRUGPropofol only TIVA
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
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Undergoing general anesthesia for elective surgery 2. Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions 3. No documented allergy/adverse reaction to propofol 4. English speaking 5. At least 18 years of age
Exclusion criteria
1. Any anti-nausea medication taken within 24 hours prior to surgery 2. Unable to provide consent independently 3. Allergy or adverse reaction to propofol 4. Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of Post Operative Nausea/Vomiting (PONV) | PACU | 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. |
| Use of Antiemetics | 24 hours | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSonal Sharma, MD
Assistant Professor, Department of Anesthesiology and Perioperative Medicine
Participant flow
Recruitment details
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.
Pre-assignment details
After written informed consent, participants were randomized prior to induction of anesthesia using a computer-based randomization tool. Allocation occurred as planned, with no delays, protocol deviations, or participant withdrawals during this interval.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.25 years |
| ASA physical status ASA I | 1 Participants |
| ASA physical status ASA II | 26 Participants |
| ASA physical status ASA III | 6 Participants |
| Body Mass Index (BMI, kg/m²) | 29 kg/m² |
| Number of smokers | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 0 / 32 | 0 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 |
Outcome results
None listed