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Food Related Video and the Incidence of Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual exposure to taped food preparation
Visual exposure to topics not related to food
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-40 years old female
  • American Society of Anesthesiologists Physical Status I and II
  • Personal history of postoperative nausea and vomiting
  • Personal history of motion sickness
  • Non-smoker status
  • Undergoing scheduled elective surgical procedures and general anesthesia for non-cancer surgery of:
  • breast
  • gynecology
  • ear, nose and throat
  • eye
  • Duration of surgery less than 3 hours will be enrolled in the study.

Exclusion Criteria:

  • Ages older than 40 years and younger than 18 years
  • Morbid obesity (BMI > 35 kg/m2)
  • Uncontrolled gastroesophageal reflux disease (GERD)
  • Smoking
  • Cancer and chemotherapy
  • Vertigo
  • Meniere's disease
  • Pseudotumor cerebri and other central nervous diseases that may induce nausea and vomiting
  • Prolonged (> 15 minutes) intraoperative hypotension
  • Estimated blood loss > 20 % of estimated blood volume
  • Emergency surgery

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Placebo group

Arm Description

The study group will watch 15 minute long videos of cooking and preparing the food of the patient's preferred type of food prior to be taken to the operating room.

The control group will watch 15 minute long non-food related videos.

Outcomes

Primary Outcome Measures

Change of the incidence of postoperative vomiting
The number of the episodes of emesis will be counted and recorded in the patients' records.
Change of postoperative anti emetic drug administration
The type and dose of administered antiemetic drugs will be recorded and analyzed in the patients' charts.

Secondary Outcome Measures

Change of recovery room length of stay
The time between arriving to and discharge from the recovery room will be recorded in the patients' charts.

Full Information

First Posted
January 18, 2021
Last Updated
May 22, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04719910
Brief Title
Food Related Video and the Incidence of Postoperative Nausea and Vomiting
Official Title
The Putative Role of the Pavlovian Reflex as a Non-pharmacological Preoperative Intervention in the Prevention of Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Postoperative nausea/vomiting (PONV) is a common problem following surgery and anesthesia. There are risk factors that increase the incidence of PONV that are related to the patient, to the surgical procedure or to the anesthetic agents. At the subjective level PONV is described as worse and more feared than postoperative pain by many patients. At the objective level it increases the length of stay in the recovery room, it results in unplanned hospital admission and Emergency Room visits, and therefore increased cost of care. A lot of research work has been done to identify pharmacological agents to prevent and treat PONV. The higher the risk of a patient the higher number of these drugs are combined for prophylaxis. However, these drugs have significant side effects of their own. Much less attention has been paid to potential non-pharmacological PONV prevention options. The purpose of our study is to investigate the putative role of the natural stimulation of normal gastrointestinal function via the Pavlovian reflex. We seek to find a natural method with no side effects to improve PONV prophylaxis in patients with risk factors for that postoperative complication.
Detailed Description
The study will be conducted in 18-40 years old female volunteers who are undergoing planned, elective, non-cancer surgical procedure as outpatients, and who are identified to have either history or significant risk of PONV. The latter will be calculated by the questionnaire we currently use during our routine preoperative anesthesia evaluation (see in detail below in the Study design section). Patients who meet the study enrollment criteria will be identified on the surgical schedule the day before the planned intervention. The recruitment will occur during the preoperative admission process. These patients will be randomly assigned to either the study group or to the control group. The study group will watch videos of preparation and cooking of their favorite foods while waiting for their surgery. Patients in the control group will watch videos that are not food related. The anesthesia team in the OR and the PACU team who manages the patient's postoperative recovery will be blinded to which group the patient is enrolled to. The intraoperative antiemetics will be provided by the study team as outlined in the Study design section below. The anesthesia protocol will be standardized. All patient who are enrolled in the study will require general anesthesia with endotracheal intubation. After intravenous induction, muscle relaxation with rocuronium and intubation of the trachea anesthesia will be maintained with sevoflurane and opioid boluses for analgesia as deemed necessary by the anesthesia team. Antiemetics (as described below) will be administered 30 minutes prior to planned emergence, residual muscle relaxant will be reversed with sugammadex. The patients will be taken to the recovery room. Beyond their routine vital sign and pain score monitoring and observation the occurrence and degree of nausea and vomiting, as well as the time to discharge to home or unplanned admission due to therapy resistant vomiting will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
The study group will watch 15 minute long videos of cooking and preparing the food of the patient's preferred type of food prior to be taken to the operating room.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The control group will watch 15 minute long non-food related videos.
Intervention Type
Other
Intervention Name(s)
Visual exposure to taped food preparation
Intervention Description
Patients in the study group can watch the preparation of the the type of food she prefers to eat normally.
Intervention Type
Other
Intervention Name(s)
Visual exposure to topics not related to food
Intervention Description
Patients in the placebo group can choose a video that is relaxing but not related to food.
Primary Outcome Measure Information:
Title
Change of the incidence of postoperative vomiting
Description
The number of the episodes of emesis will be counted and recorded in the patients' records.
Time Frame
Immediately postoperative
Title
Change of postoperative anti emetic drug administration
Description
The type and dose of administered antiemetic drugs will be recorded and analyzed in the patients' charts.
Time Frame
Immediate postoperative
Secondary Outcome Measure Information:
Title
Change of recovery room length of stay
Description
The time between arriving to and discharge from the recovery room will be recorded in the patients' charts.
Time Frame
Immediate postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-40 years old female American Society of Anesthesiologists Physical Status I and II Personal history of postoperative nausea and vomiting Personal history of motion sickness Non-smoker status Undergoing scheduled elective surgical procedures and general anesthesia for non-cancer surgery of: breast gynecology ear, nose and throat eye Duration of surgery less than 3 hours will be enrolled in the study. Exclusion Criteria: Ages older than 40 years and younger than 18 years Morbid obesity (BMI > 35 kg/m2) Uncontrolled gastroesophageal reflux disease (GERD) Smoking Cancer and chemotherapy Vertigo Meniere's disease Pseudotumor cerebri and other central nervous diseases that may induce nausea and vomiting Prolonged (> 15 minutes) intraoperative hypotension Estimated blood loss > 20 % of estimated blood volume Emergency surgery
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Food Related Video and the Incidence of Postoperative Nausea and Vomiting

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