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

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 Overview

• Status: Recruiting
• Conditions: Nausea, Postoperative; Vomiting, Postoperative
• Intervention / Treatment: Other: nausea relief inhaler

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zaid Haddadin, MS; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com
• Study Contact Backup: Name: Colette Ngo Ndjom, MS; Phone Number: 214-947-1280; Email: ClinicalResearch@mhd.com

Study Locations

• United States
  • Texas
    • Mansfield, Texas, United States, 76063
      • Recruiting
      • Methodist Mansfield Medical Center
      • Contact: Laura Sweatt, RN; Email: ClinicalResearch@mhd.com
      • Principal Investigator: Ashley Attaway, BSN, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 chronic obstructive pulmonary disease(COPD)
• Patient intubated or sedated for the 24 hours after surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Administration Record	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.	"Up to 24 hours"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhodes index	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.	"Up to 24 hours"
Length of stay	Length of stay will be tracked via chart review (date of discharge minus date of admittance)	duration of hospital stay: date of discharge minus date of admittance)

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Ashley Attaway, RN, Methodist Mansfield Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Estimated): November 23, 2024
• Study Completion (Estimated): November 23, 2024

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 058.NUR.2020.M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No