Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion (PONV)

August 11, 2026 updated by: Revati Kanekar, Milton S. Hershey Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: 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.
Active Comparator: Propofol only TIVA
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 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Episodes of Post Operative Nausea/Vomiting (PONV)
Time Frame: 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.
PACU
Use of Antiemetics
Time Frame: 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.
24 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects Experiencing Nausea.
Time Frame: PACU upto 23 hrs.
The number of subjects self-reported nausea episodes.
PACU upto 23 hrs.
Number of Subjects Experiencing Retching.
Time Frame: PACU upto 23 hrs
Number of self-reported retching episodes (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents)
PACU upto 23 hrs
Vomiting (Forceful Expulsion of Gastric Contents) Episodes
Time Frame: 24 hours
Number of self-reported vomiting episodes
24 hours
Number of Subjects Receiving Medication for Nausea.
Time Frame: PACU upto 1 hrs
Number of subjects who received Ondansetron medication for treating nausea.
PACU upto 1 hrs
Number of Subjects Receiving Medication for Nausea - Promethazine
Time Frame: PACU upto 1 hrs.
Number of subjects receiving promethazine for nausea treatment.
PACU upto 1 hrs.
Number of Subjects Receiving Medication for Nausea.- Promethazine.
Time Frame: 24 hours.
Number of subjects receiving promethazine medication for nausea.
24 hours.
Number of Subjects Who Received Prochlorperazine
Time Frame: PACU upto 1 hr
medication administered
PACU upto 1 hr
Number of Subjects Receiving Medication for Nausea - Prochlorperazine
Time Frame: 24 hours
Number of subjects receiving medication for nausea - prochlopreazine.
24 hours
Number of Subjects Receiving Droperidol
Time Frame: PACU upto 1 hr
medication administered
PACU upto 1 hr
Number of Subject Receiving Scopolamine Patch
Time Frame: 24 hours
medication administered
24 hours
Number of Subjects Experiencing Nausea (Urge to Vomit Episodes)
Time Frame: 24 hours
Number of subjects experiencing nausea.
24 hours
Number of Subjects Experiencing Retching Contents)
Time Frame: 24 hours
Number of subjects who experienced retching and self-reported it. (labored, spasmodic, rhythmic contractions of respiratory scales without expulsion of gastric episodes
24 hours
Number of Subjected Experiencing Vomiting (Forceful Expulsion of Gastric Contents) Episodes
Time Frame: 24 hours
Number of subjects experiencing vomiting (forceful expulsion of gastric contents)
24 hours
Number of Subjects Receiving Ondansetron
Time Frame: 24 hours
Number of subjects receiving ondansetron.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sonal Sharma, MD, Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00021935

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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