Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

NCT ID: NCT05759481

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-03-12

Brief Summary

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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

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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

Conditions

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Post-operative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol is administered starting at surgery induction and ending at skin closure

Placebo

Same volume of 0.9% normal saline as the study group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is administered starting at surgery induction and ending at skin closure

Interventions

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Propofol

Propofol is administered starting at surgery induction and ending at skin closure

Intervention Type DRUG

Placebo

Placebo is administered starting at surgery induction and ending at skin closure

Intervention Type OTHER

Other Intervention Names

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2,6 di-isopropylphenol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sonal Sharma

Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sonal Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Locations

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Penn State Health Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00021935

Identifier Type: -

Identifier Source: org_study_id

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