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

Primary Purpose

Post-operative Nausea and Vomiting

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Propofol
Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Nausea and Vomiting focused on measuring Post-Operative Nausea, Post-Operative Vomiting, propofol, motion sickness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Undergoing general anesthesia for elective surgery Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions No documented allergy/adverse reaction to propofol English speaking At least 18 years of age Exclusion Criteria: Any anti-nausea medication taken within 24 hours prior to surgery Unable to provide consent independently Allergy or adverse reaction to propofol Emergency surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Propofol

    Placebo

    Arm Description

    Low-dose propofol infusion at 25 mcg/kg/min

    Same volume of 0.9% normal saline as the study group

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Choice of antiemetic- Dexamethasone
    medication administered.
    Number of times dexamethasone administered
    frequency of administration
    Choice of antiemetic- Ondansetron
    medication administered.
    Number of times ondansetron administered
    frequency of administration
    Choice of antiemetic- Promethazine
    medication administered
    Number of times promethazine administered
    frequency of administration
    Choice of antiemetic- metoclopramide
    medication administered
    Number of times metoclopramide administered
    frequency of administration
    Choice of antiemetic- Prochlorperazine
    medication administered
    Number of times prochlorperazine administered
    frequency of administration
    Choice of antiemetic- Droperidol
    medication administered
    Number of times droperidol administered
    frequency of administration
    Choice of antiemetic- scopolamine
    medication administered
    Number of times scopolamine administered
    frequency of administration
    Choice of antiemetic-diphenhydramine
    medication administered
    Number of times diphenhydramine administered
    frequency of administration

    Full Information

    First Posted
    February 22, 2023
    Last Updated
    July 6, 2023
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05759481
    Brief Title
    Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
    Acronym
    PONV
    Official Title
    Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    April 2026 (Anticipated)
    Study Completion Date
    April 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    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

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Nausea and Vomiting
    Keywords
    Post-Operative Nausea, Post-Operative Vomiting, propofol, motion sickness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Propofol
    Arm Type
    Experimental
    Arm Description
    Low-dose propofol infusion at 25 mcg/kg/min
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Same volume of 0.9% normal saline as the study group
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Other Intervention Name(s)
    2,6 di-isopropylphenol
    Intervention Description
    Propofol is administered starting at surgery induction and ending at skin closure
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo is administered starting at surgery induction and ending at skin closure
    Primary Outcome Measure Information:
    Title
    Nausea (urge to vomit) episodes
    Description
    Number of self-reported nausea episodes
    Time Frame
    24 hours
    Title
    Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes
    Description
    Number of self-reported retching episodes
    Time Frame
    24 hours
    Title
    Vomiting (forceful expulsion of gastric contents) episodes
    Description
    Number of self-reported vomiting episodes
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Choice of antiemetic- Dexamethasone
    Description
    medication administered.
    Time Frame
    24 hours
    Title
    Number of times dexamethasone administered
    Description
    frequency of administration
    Time Frame
    24 hours
    Title
    Choice of antiemetic- Ondansetron
    Description
    medication administered.
    Time Frame
    24 hours
    Title
    Number of times ondansetron administered
    Description
    frequency of administration
    Time Frame
    24 hours
    Title
    Choice of antiemetic- Promethazine
    Description
    medication administered
    Time Frame
    24 hours
    Title
    Number of times promethazine administered
    Description
    frequency of administration
    Time Frame
    24 hours
    Title
    Choice of antiemetic- metoclopramide
    Description
    medication administered
    Time Frame
    24 hours
    Title
    Number of times metoclopramide administered
    Description
    frequency of administration
    Time Frame
    24 hours
    Title
    Choice of antiemetic- Prochlorperazine
    Description
    medication administered
    Time Frame
    24 hours
    Title
    Number of times prochlorperazine administered
    Description
    frequency of administration
    Time Frame
    24 hours
    Title
    Choice of antiemetic- Droperidol
    Description
    medication administered
    Time Frame
    24 hours
    Title
    Number of times droperidol administered
    Description
    frequency of administration
    Time Frame
    24 hours
    Title
    Choice of antiemetic- scopolamine
    Description
    medication administered
    Time Frame
    24 hours
    Title
    Number of times scopolamine administered
    Description
    frequency of administration
    Time Frame
    24 hours
    Title
    Choice of antiemetic-diphenhydramine
    Description
    medication administered
    Time Frame
    24 hours
    Title
    Number of times diphenhydramine administered
    Description
    frequency of administration
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Undergoing general anesthesia for elective surgery Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions No documented allergy/adverse reaction to propofol English speaking At least 18 years of age Exclusion Criteria: Any anti-nausea medication taken within 24 hours prior to surgery Unable to provide consent independently Allergy or adverse reaction to propofol Emergency surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cynthia Reed
    Phone
    7175310003
    Ext
    282465
    Email
    creed@pennstatehealth.psu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ruth Jarbadan
    Phone
    7175316135
    Email
    njarbadan@pennstatehealth.psu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sonal Sharma, MD
    Organizational Affiliation
    Assistant Professor, Department of Anesthesiology and Perioperative Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

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