Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery. (DDA-PONV)

February 24, 2025 updated by: Insel Gruppe AG, University Hospital Bern

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Verum
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).
Drug: Aprepitant 80 mg
Encapsulated capsule of aprepitant 80mg to make it look alike to the placebo.
Other Names:
  • Aprepitant Zentiva 80mg
Placebo Comparator: Placebo
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.
Drug: Placebo
Encapsulated placebo capsules for optical, acoustical and haptic blinding.
Other Names:
  • Placebo Capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of nausea
Time Frame: 3, 24 and 48 hours after surgery
mild [NRS 1-3], moderate [NRS 4-6] and severe [NRS 7-10]
3, 24 and 48 hours after surgery
Incidence of emesis
Time Frame: 3, 24 and 48 hours after surgery
number
3, 24 and 48 hours after surgery
Use of rescue medication for PONV
Time Frame: 3, 24 and 48 hours after surgery
medication, cumulative dose, route
3, 24 and 48 hours after surgery
Use of opioid analgesics
Time Frame: 3, 24 and 48 hours after surgery
mg of oral morphine equivalents
3, 24 and 48 hours after surgery
Use of non-opioid analgesics
Time Frame: 3, 24 and 48 hours after surgery
medication, cumulative dose, route
3, 24 and 48 hours after surgery
Use of co-analgesics
Time Frame: 3, 24 and 48 hours after surgery
medication, cumulative dose, route
3, 24 and 48 hours after surgery
Rate of delayed PACU discharge because of PONV
Time Frame: 24 hours after surgery
number
24 hours after surgery
Length of PACU stay
Time Frame: 24 hours after surgery
hours
24 hours after surgery
Length of hospital stay
Time Frame: 48 hours after surgery
hours
48 hours after surgery
Surgical complications at 30 days after surgery
Time Frame: 30 days
using Clavien-Dindo classification (number and grade)
30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 3, 24 and 48 hours after surgery, 30 days after surgery
pre-defined events, safety outcome
3, 24 and 48 hours after surgery, 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian M Beilstein, MD, Bern University Hospital, University of Bern, Bern, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BECD-2-21

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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