Postoperative Nausea and VomitingPhase 4DDA-PONVNCT05189756
Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery.
A Phase 4 study testing Aprepitant 80 mg in people with Postoperative Nausea and Vomiting and Bariatric Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Postoperative nausea and vomiting (PONV) is unpleasant and increases health care costs. Despite modern techniques and prophylaxis, PONV rates remain high after laparoscopic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Bariatric Surgery
- What is being tested?
- Aprepitant 80 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Mar 2022to 20 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and more
- Scheduled for an elective, laparoscopic bariatric surgery (either laparoscopic gastric sleeve resection or laparoscopic gastric bypass)
- BMI > 30 kg/m2
- moderate to high risk for PONV (defined as APFEL score of 2 or higher)
- Informed Consent as documented by signature (see appendix 2).
Who cannot join
- emergency or open abdominal surgery;
- contraindication to aprepitant:
- known allergy/hypersensitivity
- on pimozide, terfenadine, astemizole or cisapride
- on regular medication with known interaction with the study drug:
- benzodiazepines
Show all 27Show fewer
- ketoconazole, itraconazole
- rifampicin, clarithromycin
- paroxetine
- diltiazem
- carbamazepine, phenytoin
- tolbutamid
- ritonavir
- St. John's wort
- patients with history of chronic nausea/vomiting or taking medication with known antiemetic properties (dexamethasone, metoclopramide, meclozine)
- severe hepatic impairment (Child-Pugh score >9);
- chronic substance abuse (except smoking);
- significant psychiatric disease precluding interrogation;
- Inability to follow the procedures of the study, e. g. due to language barrier;
- Women who are pregnant or breast feeding;
- Intention to become pregnant during the course of the study and 2 months after surgery;
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a condom in addition to a medically reliable method of contraception for the entire study duration and 2 months after surgery, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- male participants need to use a condom for the whole study period and 2 months after surgery;
- unable to consent, e. g. patients incapable of judgment needing next-of-kin consent or under tutelage;
- participation in another study with an investigational drug within the 30 days preceding and during the present study;
- previous enrolment into the current study;
- enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern
Bern, 3010
About this study
Official title: Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery: a Prospective, Randomised, Placebo-controlled, Triple-blind, Single Centre Trial.
Postoperative nausea and vomiting (PONV) is unpleasant and increases health care costs. Despite modern techniques and prophylaxis, PONV rates remain high after laparoscopic bariatric surgery. We aim to reduce PONV after laparoscopic bariatric surgery using aprepitant with a similar scheme used for emetogenic chemotherapy.
Read the detailed description
Postoperative nausea and vomiting (PONV) is not only a disturbing and unpleasant experience for the patient, it also increases length of post anaesthesia care unit (PACU) and hospital stay. In addition, PONV increases the risk for unplanned admission, risk for complications and in the end, health care costs. Risk factors have been identified more than 20 years ago by Apfel et. al., whose screening score has been widely implemented to augment perioperative prophylaxis. But despite modern anaesthetic techniques and combined antiemetic prophylaxis, PONV rates remain high in patients at high risk for PONV: in a recent retrospective study in female patients after laparoscopic bariatric surgery, up to 68% suffered from PONV during the first 48 hours after surgery despite triple antiemetic prophylaxis. While aprepitant is prescribed for three consecutive days after chemotherapy, there is no study so far evaluating the effect of a second dose of aprepitant 24 hours after surgery to prevent the increase in PONV after PACU discharge. We hypothesise, that adding two scheduled doses of aprepitant (2 hours before and 24 hours after surgery) to a twofold antiemetic regimen will significantly reduce cumulative PONV in the first 48 hours after laparoscopic bariatric surgery in patients with moderate to high risk for PONV.
- Being tested
- Aprepitant 80 mg, Placebo
- 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.
Aprepitant 80 mgDrug
Also called Aprepitant Zentiva 80mg
Encapsulated capsule of aprepitant 80mg to make it look alike to the placebo.
PlaceboDrug
Also called Placebo Capsules
Encapsulated placebo capsules for optical, acoustical and haptic blinding.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Patients will receive 2 encapsulated capsules containing aprepitant 80mg to be ingested with a sip of water 2 hours before surgery and 24 hours after surgery. Surgery will follow our hospital enhanced recovery after surgery (ERAS) standard (general anaesthesia using volatile anaesthetics, intravenous dexamethasone 8mg and ondansetron 4mg for PONV prophylaxis). Receives: Drug: Aprepitant 80 mg |
| Placebo | Placebo comparator | Patients will receive similar looking encapsulated capsules containing only placebo to be ingested with a sip of water 2 hours before surgery and 24 hours after surgery. Surgical and anaesthetic procedures are identical to the verum arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of PONV 48 hours after surgery
Primary outcome is cumulative rate of PONV (defined as emesis including vomiting and retching, severe nausea [>6/10 on a numeric rating scale (NRS)] and use of rescue medication) at 48 hours after surgery.
Measured: 48 hours
Secondary outcomes (10)
Severity of nausea
mild [NRS 1-3], moderate [NRS 4-6] and severe [NRS 7-10]
Measured: 3, 24 and 48 hours after surgery
Incidence of emesis
number
Measured: 3, 24 and 48 hours after surgery
Use of rescue medication for PONV
medication, cumulative dose, route
Measured: 3, 24 and 48 hours after surgery
Use of opioid analgesics
mg of oral morphine equivalents
Measured: 3, 24 and 48 hours after surgery
Use of non-opioid analgesics
medication, cumulative dose, route
Measured: 3, 24 and 48 hours after surgery
Use of co-analgesics
medication, cumulative dose, route
Measured: 3, 24 and 48 hours after surgery
Rate of delayed PACU discharge because of PONV
number
Measured: 24 hours after surgery
Length of PACU stay
hours
Measured: 24 hours after surgery
Length of hospital stay
hours
Measured: 48 hours after surgery
Surgical complications at 30 days after surgery
using Clavien-Dindo classification (number and grade)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start17 Mar 2022
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Why it stopped: Low recruiting rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- This is a prospective, randomised, placebo-controlled, triple-blind, single centre, two-arm parallel groups superiority trial assessing incidence of PONV 48 hours after laparoscopic bariatric surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian M Beilstein, MD, Principal investigator, Bern University Hospital, University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189756
- Sponsor's protocol ID
- BECD-2-21
- Acronym
- DDA-PONV
- Status last verified
- Feb 2025
- First submitted
- 28 Dec 2021
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery: a Prospective, Randomised, Placebo-controlled, Triple-blind, Single Centre Trial.
- ClinicalTrials.gov ID
- NCT05189756
- Acronym / sponsor ID
- DDA-PONV / BECD-2-21
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruiting rate
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 12 Jan 2022 (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.
Postoperative nausea and vomiting (PONV) is unpleasant and increases health care costs. Despite modern techniques and prophylaxis, PONV rates remain high after laparoscopic bariatric surgery. We aim to reduce PONV after laparoscopic bariatric surgery using aprepitant with a similar scheme used for emetogenic chemotherapy.
Detailed description
Postoperative nausea and vomiting (PONV) is not only a disturbing and unpleasant experience for the patient, it also increases length of post anaesthesia care unit (PACU) and hospital stay. In addition, PONV increases the risk for unplanned admission, risk for complications and in the end, health care costs. Risk factors have been identified more than 20 years ago by Apfel et. al., whose screening score has been widely implemented to augment perioperative prophylaxis. But despite modern anaesthetic techniques and combined antiemetic prophylaxis, PONV rates remain high in patients at high risk for PONV: in a recent retrospective study in female patients after laparoscopic bariatric surgery, up to 68% suffered from PONV during the first 48 hours after surgery despite triple antiemetic prophylaxis. While aprepitant is prescribed for three consecutive days after chemotherapy, there is no study so far evaluating the effect of a second dose of aprepitant 24 hours after surgery to prevent the increase in PONV after PACU discharge. We hypothesise, that adding two scheduled doses of aprepitant (2 hours before and 24 hours after surgery) to a twofold antiemetic regimen will significantly reduce cumulative PONV in the first 48 hours after laparoscopic bariatric surgery in patients with moderate to high risk for PONV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomised, placebo-controlled, triple-blind, single centre, two-arm parallel groups superiority trial assessing incidence of PONV 48 hours after laparoscopic bariatric surgery.
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: Aprepitant 80 mgPatients will receive 2 encapsulated capsules containing aprepitant 80mg to be ingested with a sip of water 2 hours before surgery and 24 hours after surgery. Surgery will follow our hospital enhanced recovery after surgery (ERAS) standard (general anaesthesia using volatile anaesthetics, intravenous dexamethasone 8mg and ondansetron 4mg for PONV prophylaxis). |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive similar looking encapsulated capsules containing only placebo to be ingested with a sip of water 2 hours before surgery and 24 hours after surgery. Surgical and anaesthetic procedures are identical to the verum arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 and more
- Scheduled for an elective, laparoscopic bariatric surgery (either laparoscopic gastric sleeve resection or laparoscopic gastric bypass)
- BMI > 30 kg/m2
- moderate to high risk for PONV (defined as APFEL score of 2 or higher)
- Informed Consent as documented by signature (see appendix 2).
Key exclusion criteria (27 listed)
- emergency or open abdominal surgery;
- contraindication to aprepitant:
- on regular medication with known interaction with the study drug:
- patients with history of chronic nausea/vomiting or taking medication with known antiemetic properties (dexamethasone, metoclopramide, meclozine)
- severe hepatic impairment (Child-Pugh score >9);
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 |
|---|---|---|
| Aprepitant 80 mgAlso: Aprepitant Zentiva 80mgEncapsulated capsule of aprepitant 80mg to make it look alike to the placebo. | Drug | Verum |
| PlaceboAlso: Placebo CapsulesEncapsulated placebo capsules for optical, acoustical and haptic blinding. | Drug | Placebo |
Primary outcome
Cumulative rate of PONV 48 hours after surgery
Time frame: 48 hours
Primary outcome is cumulative rate of PONV (defined as emesis including vomiting and retching, severe nausea [>6/10 on a numeric rating scale (NRS)] and use of rescue medication) at 48 hours after surgery.
10 secondary outcomes
Severity of nausea
Time frame: 3, 24 and 48 hours after surgery
Incidence of emesis
Time frame: 3, 24 and 48 hours after surgery
Use of rescue medication for PONV
Time frame: 3, 24 and 48 hours after surgery
Use of opioid analgesics
Time frame: 3, 24 and 48 hours after surgery
Use of non-opioid analgesics
Time frame: 3, 24 and 48 hours after surgery
Use of co-analgesics
Time frame: 3, 24 and 48 hours after surgery
Rate of delayed PACU discharge because of PONV
Time frame: 24 hours after surgery
Length of PACU stay
Time frame: 24 hours after surgery
Length of hospital stay
Time frame: 48 hours after surgery
Surgical complications at 30 days after surgery
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Low recruiting rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea and Vomiting
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Christian M Beilstein, MD principal investigator
Bern University Hospital, University of Bern, Bern, Switzerland
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 80 mg in people with Postoperative Nausea and Vomiting and Bariatric Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 27 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: stopped early, as of the sponsor's last update on 27 Feb 2025. 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 Switzerland. 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?
The study was stopped early (reason given: Low recruiting rate). 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?
Cumulative rate of PONV 48 hours after surgery (time frame: 48 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 27 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.