Clinical trial NCT04719910: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of the incidence of postoperative vomiting
timeFrame: Immediately postoperative
measure: Change of postoperative anti emetic drug administration
timeFrame: Immediate postoperative
Secondary outcomes:
measure: Change of recovery room length of stay
timeFrame: Immediate postoperative
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
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