Clinical trial NCT06110416: Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient
Official title: Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nausea, Postoperative
Vomiting, Postoperative
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Administration Record
timeFrame: "Up to 24 hours"
Secondary outcomes:
measure: Rhodes index
timeFrame: "Up to 24 hours"
measure: Length of stay
timeFrame: duration of hospital stay: date of discharge minus date of admittance)
Other outcomes:
Locations:
city: Mansfield
country: United States
facility: Methodist Mansfield Medical Center
state: Texas
Study officials:
affiliation: Methodist Mansfield Medical Center
name: Ashley Attaway, RN
role: PRINCIPAL_INVESTIGATOR
References: