Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT06110416
Collaborator
(none)
50
1
1
35
1.4

Study Details

Study Description

Brief Summary

From the research and current studies, post-operative nausea and vomiting is a common complaint after bariatric surgery. Nausea relief inhalers could improve post-operative nausea and vomiting without the need for further medications, subsequently reducing the chance of side effects. This study could help improve patient satisfaction and increase the ability of the patient to ambulate after surgery with the use of a nausea relief inhaler.

Condition or Disease Intervention/Treatment Phase
  • Other: nausea relief inhaler
N/A

Detailed Description

Post-operative nausea and vomiting is a very common and uncomfortable issue that occurs after bariatric surgery. 65% of patients have post-operative nausea and vomiting. Compared to previously published results, this percentage was higher than patients undergoing ambulatory surgery. The most common start of post-operative nausea and vomiting was in the first six hours but continued to increase during the first 24 hours. Post-operative nausea and vomiting inhibits early mobilization for the patient affected. Even patients that received nausea and vomiting prophylaxis at the optimal amount had an 82% of occurrence of nausea and vomiting. Post-operative nausea and vomiting occurred in 59% of the population that received greater than optimal prophylaxis. Researchers speculate that the high incidence of nausea and vomiting occurs due to potential damage of the vagal nerve during the operation. The motility of the stomach and intestines is also affected by the surgery and narcotics that patients take after the operation. Halliday and colleagues concluded that other methods of nausea and vomiting prevention should be evaluated in this population.

Aromatherapy and essential oils are an alternative method to controlling post-operative nausea and vomiting after post-surgical intervention. Although it has not been frequently studied in bariatric patients, it has been studied post-operatively for other surgeries and for vomiting after chemotherapy. According to a systematic review in 2012, three studies regarding post-operative nausea and vomiting found reduction in symptoms after inhalation of essential oils. The studies also noted reduction in need for nausea medication, improved patient satisfaction, and reduction in cost. A review by Cochrane and colleagues showed no reliable evidence of the effectiveness of peppermint oil. Other studies found that either peppermint or ginger were effective in the reduction of post-operative nausea and vomiting. However the studies had relatively small sample sizes and were not usually randomized control trials.

From the research and current studies, post-operative nausea and vomiting is a common complaint after bariatric surgery. Nausea relief inhalers could improve post-operative nausea and vomiting without the need for further medications, subsequently reducing the chance of side effects. This study could help improve patient satisfaction and increase the ability of the patient to ambulate after surgery with the use of a nausea relief inhaler.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient
Actual Study Start Date :
Dec 23, 2020
Anticipated Primary Completion Date :
Nov 23, 2023
Anticipated Study Completion Date :
Nov 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Aromatherapy

Other: nausea relief inhaler
Aromatherapy and essential oils are an alternative method to controlling post-operative nausea and vomiting after post-surgical intervention.

Outcome Measures

Primary Outcome Measures

  1. Medication Administration Record ["Up to 24 hours"]

    The amount of nausea and vomiting medication use will be determined by the medication administration record during chart review in the first 24 hours for each study patient.

Secondary Outcome Measures

  1. Rhodes index ["Up to 24 hours"]

    Indicators of decreased stress and increased contentment will be found by patient's answers to questions regarding distress from dry heaving and retching and nausea and vomiting.

  2. Length of stay [duration of hospital stay: date of discharge minus date of admittance)]

    Length of stay will be tracked via chart review (date of discharge minus date of admittance)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 18 to 65 years old

  • Attend the pre-operative class

  • Must be able to read English

  • Admitted to B4 surgical acute unit

  • Surgery after May 31st, 2020

Exclusion Criteria:
  • BMI greater than 60

  • Pre-operatively on nausea medication

  • Allergy to spearmint, lemon, ginger, and/or cedarwood

  • History of Asthma or COPD

  • Patient intubated or sedated for the 24 hours after surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Mansfield Medical Center Mansfield Texas United States 76063

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Ashley Attaway, RN, Methodist Mansfield Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT06110416
Other Study ID Numbers:
  • 058.NUR.2020.M
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023