Nausea, PostoperativeNCT06110416
Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient
A study testing nausea relief inhaler in people with Nausea, Postoperative and Vomiting, Postoperative, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nausea, Postoperative, Vomiting, Postoperative
- What is being tested?
- nausea relief inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Mansfield Medical Center
Mansfield, Texas, 76063
About this study
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.
Read the 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.
- Conditions
- Nausea, Postoperative, Vomiting, Postoperative
- Being tested
- nausea relief inhaler
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nausea relief inhalerOther
Aromatherapy and essential oils are an alternative method to controlling post-operative nausea and vomiting after post-surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Other | Not described Receives: Other: nausea relief inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "Up to 24 hours"
Secondary outcomes (2)
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.
Measured: "Up to 24 hours"
Length of stay
Length of stay will be tracked via chart review (date of discharge minus date of admittance)
Measured: duration of hospital stay: date of discharge minus date of admittance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start23 Dec 2020
- Primary completion20 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Attaway, RN, Principal investigator, Methodist Mansfield Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110416
- Sponsor's protocol ID
- 058.NUR.2020.M
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient
- ClinicalTrials.gov ID
- NCT06110416
- Acronym / sponsor ID
- 058.NUR.2020.M
- Conditions
- Nausea, Postoperative, Vomiting, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Other | Other: nausea relief inhaler |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nausea relief inhalerAromatherapy and essential oils are an alternative method to controlling post-operative nausea and vomiting after post-surgical intervention. | Other | Aromatherapy |
Primary outcome
Medication Administration Record
Time frame: "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.
2 secondary outcomes
Rhodes index
Time frame: "Up to 24 hours"
Length of stay
Time frame: duration of hospital stay: date of discharge minus date of admittance)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Attaway, RN principal investigator
Methodist Mansfield Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nausea relief inhaler in people with Nausea, Postoperative and Vomiting, Postoperative, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Administration Record (time frame: "Up to 24 hours"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.