Clinical trial NCT05759481: Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
Official title: Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-operative Nausea and Vomiting
Keywords: Post-Operative Nausea
Post-Operative Vomiting
propofol
motion sickness
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Nausea (urge to vomit) episodes
timeFrame: 24 hours
measure: Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes
timeFrame: 24 hours
measure: Vomiting (forceful expulsion of gastric contents) episodes
timeFrame: 24 hours
Secondary outcomes:
measure: Choice of antiemetic- Dexamethasone
timeFrame: 24 hours
measure: Number of times dexamethasone administered
timeFrame: 24 hours
measure: Choice of antiemetic- Ondansetron
timeFrame: 24 hours
measure: Number of times ondansetron administered
timeFrame: 24 hours
measure: Choice of antiemetic- Promethazine
timeFrame: 24 hours
measure: Number of times promethazine administered
timeFrame: 24 hours
measure: Choice of antiemetic- metoclopramide
timeFrame: 24 hours
measure: Number of times metoclopramide administered
timeFrame: 24 hours
measure: Choice of antiemetic- Prochlorperazine
timeFrame: 24 hours
measure: Number of times prochlorperazine administered
timeFrame: 24 hours
measure: Choice of antiemetic- Droperidol
timeFrame: 24 hours
measure: Number of times droperidol administered
timeFrame: 24 hours
measure: Choice of antiemetic- scopolamine
timeFrame: 24 hours
measure: Number of times scopolamine administered
timeFrame: 24 hours
measure: Choice of antiemetic-diphenhydramine
timeFrame: 24 hours
measure: Number of times diphenhydramine administered
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Assistant Professor, Department of Anesthesiology and Perioperative Medicine
name: Sonal Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: