Food Related Video and the Incidence of Postoperative Nausea and Vomiting

NCT04719910 | Completed

• 1 other identifier: ANES-2021-29548
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• Change of the incidence of postoperative vomiting

  The number of the episodes of emesis will be counted and recorded in the patients' records.

  Immediately postoperative

• Change of postoperative anti emetic drug administration

  The type and dose of administered antiemetic drugs will be recorded and analyzed in the patients' charts.

  Immediate postoperative

Secondary Outcomes (1)

• Change of recovery room length of stay

  Immediate postoperative

Study Arms (2)

Study group

EXPERIMENTAL

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.

Other: Visual exposure to taped food preparation

Placebo group

PLACEBO COMPARATOR

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

Other: Visual exposure to topics not related to food

Interventions

Visual exposure to taped food preparation OTHER

Patients in the study group can watch the preparation of the the type of food she prefers to eat normally.

Study group

Visual exposure to topics not related to food OTHER

Patients in the placebo group can choose a video that is relaxing but not related to food.

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (16)

• Amirshahi M, Behnamfar N, Badakhsh M, Rafiemanesh H, Keikhaie KR, Sheyback M, Sari M. Prevalence of postoperative nausea and vomiting: A systematic review and meta-analysis. Saudi J Anaesth. 2020 Jan-Mar;14(1):48-56. doi: 10.4103/sja.SJA_401_19. Epub 2020 Jan 6.

  PMID: 31998020 BACKGROUND

• Hirsch J. Impact of postoperative nausea and vomiting in the surgical setting. Anaesthesia. 1994 Jan;49 Suppl:30-3. doi: 10.1111/j.1365-2044.1994.tb03580.x.

  PMID: 8129160 BACKGROUND

• Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.

  PMID: 10475299 BACKGROUND

• Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.

  PMID: 16846542 BACKGROUND

• Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.

  PMID: 9717590 BACKGROUND

• Dzwonczyk R, Weaver TE, Puente EG, Bergese SD. Postoperative nausea and vomiting prophylaxis from an economic point of view. Am J Ther. 2012 Jan;19(1):11-5. doi: 10.1097/MJT.0b013e3181e7a512.

  PMID: 20634672 BACKGROUND

• Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.

  PMID: 15190136 BACKGROUND

• Gan TJ. Mechanisms underlying postoperative nausea and vomiting and neurotransmitter receptor antagonist-based pharmacotherapy. CNS Drugs. 2007;21(10):813-33. doi: 10.2165/00023210-200721100-00003.

  PMID: 17850171 BACKGROUND

• Lee A, Done ML. The use of nonpharmacologic techniques to prevent postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999 Jun;88(6):1362-9. doi: 10.1097/00000539-199906000-00031.

  PMID: 10357346 BACKGROUND

• Darvall JN, Handscombe M, Leslie K. Chewing gum for the treatment of postoperative nausea and vomiting: a pilot randomized controlled trial. Br J Anaesth. 2017 Jan;118(1):83-89. doi: 10.1093/bja/aew375.

  PMID: 28039245 BACKGROUND

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

  PMID: 10485781 BACKGROUND

• Pierre S, Benais H, Pouymayou J. Apfel's simplified score may favourably predict the risk of postoperative nausea and vomiting. Can J Anaesth. 2002 Mar;49(3):237-42. doi: 10.1007/BF03020521.

  PMID: 11861340 BACKGROUND

• Sherif L, Hegde R, Mariswami M, Ollapally A. Validation of the Apfel Scoring System for Identification of High-risk Patients for PONV. Karnataka Anaesth J. 2015;1(3):115-117

  BACKGROUND

• Davis CJ, Lake-Bakaar GV, Grahame-Smith DG. Nausea and Vomiting: Mechanisms and Treatment. Springer Science & Business Media; 2012

  BACKGROUND

• Stern RM, Jokerst MD, Levine ME, Koch KL. The stomach's response to unappetizing food: cephalic-vagal effects on gastric myoelectric activity. Neurogastroenterol Motil. 2001 Apr;13(2):151-4. doi: 10.1046/j.1365-2982.2001.00250.x.

  PMID: 11298993 BACKGROUND

• Sarles H, Dani R, Prezelin G, Souville C, Figarella C. Cephalic phase of pancreatic secretion in man. Gut. 1968 Apr;9(2):214-21. doi: 10.1136/gut.9.2.214. No abstract available.

  PMID: 5655031 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: September 1, 2021
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)