ObesityPhase 4NCT05772676
The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting
A Phase 4 study testing Aprepitant in people with Obesity and Nausea and Vomiting, Postoperative, run by Hospital General Tlahuac at 1 site in Mexico.
Trial summary
The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Nausea and Vomiting, Postoperative
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2022to 1 Apr 2023
- Phase
- Phase 4
- 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
- 18 to 65 years old.
- Non-smokers.
- Obesity with BMI > 30 kg/m2.
- Undergoing laparoscopic gastric sleeve.
Who cannot join
- Documented hypersensitivity to any component of the study regimen.
- Current treatment with: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride).
- Allergy to opioid drugs used in the anesthetic protocol.
- Drug or alcohol abuse.
- Chronic nausea and vomiting.
- Previous bariatric procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery
The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen
Read the detailed description
After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery).
The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
- Conditions
- Obesity, Nausea and Vomiting, Postoperative
- Being tested
- Aprepitant, Placebo
- Keywords
- Laparoscopic Gastric Sleeve, Bariatric Surgery, Nausea and Vomiting, Postoperative, Aprepitant
- Medical subject headings
- Obesity, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery
PlaceboOther
Placebo + standard antiemetic regimen, once two hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant | Experimental | Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg Receives: Drug: Aprepitant |
| Placebo | Placebo comparator | Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale
Measured: 0 postoperative hours
Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index)
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Measured: 6 postoperative hours
Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index)
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Measured: 12 postoperative hours
Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index)
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Measured: 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Dec 2022
- Primary completion1 Jan 2023
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial conducted in obese patients undergoing laparoscopic gastric sleeve surgery to assess the efficacy of Aprepitant (80 or 125 mg) in combination with a standard antiemetic regimen (Ondansetron + Metoclopramide + Dexamethasone) is presented vs placebo + the same standard regimen, evaluating postoperative nausea and vomiting by means of a specific scale (Rhodes index) for the assessment of nausea and vomiting
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Tlahuac
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CARLOS ZERRWECK LOPEZ, Hospital General Tlahuac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772676
- Sponsor's protocol ID
- APREPITANTBAJAMED-01-2023
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ortiz E, Gonzalez AI, Jaime V, Guzman JA, Esparza I, Orozco JO, Guerrero MA, Ramos A, Zerrweck C. The impact of Aprepitant on Nausea and Vomiting following Laparoscopic Sleeve Gastrectomy: A Blinded Randomized Controlled Trial. Obes Surg. 2024 Apr;34(4):1316-1323. doi: 10.1007/s11695-024-07129-0. Epub 2024 Mar 2.
PubMed 38429485
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery
- ClinicalTrials.gov ID
- NCT05772676
- Acronym / sponsor ID
- APREPITANTBAJAMED-01-2023
- Conditions
- Obesity, Nausea and Vomiting, Postoperative
- Keywords
- Laparoscopic Gastric Sleeve, Bariatric Surgery, Nausea and Vomiting, Postoperative, Aprepitant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospital General TlahuacOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 16 Mar 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.
The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen
Detailed description
After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery).
The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial conducted in obese patients undergoing laparoscopic gastric sleeve surgery to assess the efficacy of Aprepitant (80 or 125 mg) in combination with a standard antiemetic regimen (Ondansetron + Metoclopramide + Dexamethasone) is presented vs placebo + the same standard regimen, evaluating postoperative nausea and vomiting by means of a specific scale (Rhodes index) for the assessment of nausea and vomiting
| Arm | Type | Receives |
|---|---|---|
| Aprepitant | Experimental | Drug: AprepitantAprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg |
| Placebo | Placebo comparator | Other: PlaceboPlacebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 years old.
- Non-smokers.
- Obesity with BMI > 30 kg/m2.
- Undergoing laparoscopic gastric sleeve.
Key exclusion criteria (6 listed)
- Documented hypersensitivity to any component of the study regimen.
- Current treatment with: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride).
- Allergy to opioid drugs used in the anesthetic protocol.
- Drug or alcohol abuse.
- Chronic nausea and vomiting.
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 |
|---|---|---|
| Aprepitant80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery | Drug | Aprepitant |
| PlaceboPlacebo + standard antiemetic regimen, once two hours before surgery | Other | Placebo |
Primary outcome
Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)
Time frame: 0 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale
Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index)
Time frame: 6 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index)
Time frame: 12 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index)
Time frame: 24 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 38429485Ortiz E, Gonzalez AI, Jaime V, Guzman JA, Esparza I, Orozco JO, Guerrero MA, Ramos A, Zerrweck C. The impact of Aprepitant on Nausea and Vomiting following Laparoscopic Sleeve Gastrectomy: A Blinded Randomized Controlled Trial. Obes Surg. 2024 Apr;34(4):1316-1323. doi: 10.1007/s11695-024-07129-0. Epub 2024 Mar 2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant in people with Obesity and Nausea and Vomiting, Postoperative, run by Hospital General Tlahuac at 1 site in Mexico.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index) (time frame: 0 postoperative hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05772676, which also lists 1 linked publication.
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 16 Mar 2023.