Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Phase 2

Completed

• Conditions: Post-operative Nausea and Vomiting
• Interventions: Other: Placebo; Drug: Propofol

• Registration Number: NCT05759481
• Lead Sponsor: Milton S. Hershey Medical Center

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

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-08
• Study Start: 2024-02-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-12
• Study Completion: 2025-03-12
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Same volume of 0.9% normal saline as the study group
Propofol	Propofol	Low-dose propofol infusion at 25 mcg/kg/min

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Penn State Health Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States