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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

65

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

Milton S. Hershey Medical Center

Investigators

  • 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)

February 1, 2024

Primary Completion (Actual)

March 12, 2025

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Subscribe