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

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: Post-operative Nausea and Vomiting
• Intervention / Treatment: Drug: Propofol; Other: Placebo

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): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol; Low-dose propofol infusion at 25 mcg/kg/min	Drug: Propofol; Propofol is administered starting at surgery induction and ending at skin closure; Other Names: 2,6 di-isopropylphenol
Placebo Comparator: Placebo; Same volume of 0.9% normal saline as the study group	Other: Placebo; Placebo is administered starting at surgery induction and ending at skin closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea (urge to vomit) episodes	Number of self-reported nausea episodes	24 hours
Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes	Number of self-reported retching episodes	24 hours
Vomiting (forceful expulsion of gastric contents) episodes	Number of self-reported vomiting episodes	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choice of antiemetic- Dexamethasone	medication administered.	24 hours
Number of times dexamethasone administered	frequency of administration	24 hours
Choice of antiemetic- Ondansetron	medication administered.	24 hours
Number of times ondansetron administered	frequency of administration	24 hours
Choice of antiemetic- Promethazine	medication administered	24 hours
Number of times promethazine administered	frequency of administration	24 hours
Choice of antiemetic- metoclopramide	medication administered	24 hours
Number of times metoclopramide administered	frequency of administration	24 hours
Choice of antiemetic- Prochlorperazine	medication administered	24 hours
Number of times prochlorperazine administered	frequency of administration	24 hours
Choice of antiemetic- Droperidol	medication administered	24 hours
Number of times droperidol administered	frequency of administration	24 hours
Choice of antiemetic- scopolamine	medication administered	24 hours
Number of times scopolamine administered	frequency of administration	24 hours
Choice of antiemetic-diphenhydramine	medication administered	24 hours
Number of times diphenhydramine administered	frequency of administration	24 hours

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Sonal Sharma, MD, Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Study record dates

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): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: propofol; motion sickness; Post-Operative Nausea; Post-Operative Vomiting
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• 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