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

Primary Purpose

Postoperative Nausea and Vomiting, Bariatric Surgery

Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Aprepitant 80 mg
Placebo
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of BernRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum

Placebo

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Severity of nausea
mild [NRS 1-3], moderate [NRS 4-6] and severe [NRS 7-10]
Incidence of emesis
number
Use of rescue medication for PONV
medication, cumulative dose, route
Use of opioid analgesics
mg of oral morphine equivalents
Use of non-opioid analgesics
medication, cumulative dose, route
Use of co-analgesics
medication, cumulative dose, route
Rate of delayed PACU discharge because of PONV
number
Length of PACU stay
hours
Length of hospital stay
hours
Surgical complications at 30 days after surgery
using Clavien-Dindo classification (number and grade)

Full Information

First Posted
December 28, 2021
Last Updated
May 9, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05189756
Brief Title
Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery.
Acronym
DDA-PONV
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
March 18, 2025 (Anticipated)
Study Completion Date
April 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Bariatric Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Verum, placebo and block-randomisation will be provided by hospital pharmacy. Therefore, patients, treating team and researcher will be blinded.
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aprepitant 80 mg
Other Intervention Name(s)
Aprepitant Zentiva 80mg
Intervention Description
Encapsulated capsule of aprepitant 80mg to make it look alike to the placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Capsules
Intervention Description
Encapsulated placebo capsules for optical, acoustical and haptic blinding.
Primary Outcome Measure Information:
Title
Cumulative rate of PONV 48 hours after surgery
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Severity of nausea
Description
mild [NRS 1-3], moderate [NRS 4-6] and severe [NRS 7-10]
Time Frame
3, 24 and 48 hours after surgery
Title
Incidence of emesis
Description
number
Time Frame
3, 24 and 48 hours after surgery
Title
Use of rescue medication for PONV
Description
medication, cumulative dose, route
Time Frame
3, 24 and 48 hours after surgery
Title
Use of opioid analgesics
Description
mg of oral morphine equivalents
Time Frame
3, 24 and 48 hours after surgery
Title
Use of non-opioid analgesics
Description
medication, cumulative dose, route
Time Frame
3, 24 and 48 hours after surgery
Title
Use of co-analgesics
Description
medication, cumulative dose, route
Time Frame
3, 24 and 48 hours after surgery
Title
Rate of delayed PACU discharge because of PONV
Description
number
Time Frame
24 hours after surgery
Title
Length of PACU stay
Description
hours
Time Frame
24 hours after surgery
Title
Length of hospital stay
Description
hours
Time Frame
48 hours after surgery
Title
Surgical complications at 30 days after surgery
Description
using Clavien-Dindo classification (number and grade)
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
pre-defined events, safety outcome
Time Frame
3, 24 and 48 hours after surgery, 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian M Beilstein, MD
Phone
+41316322111
Email
Christian.Beilstein@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Y Wuethrich, MD
Phone
+41316322111
Email
Patrick.Wuethrich@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian M Beilstein, MD
Organizational Affiliation
Bern University Hospital, University of Bern, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian M Beilstein, MD
Phone
+41 31 632 24 83
Email
Christian.Beilstein@insel.ch
First Name & Middle Initial & Last Name & Degree
Patrick Y Wüthrich, Prof, MD
Phone
+41 31 632 24 83
Email
Patrick.Wuethrich@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery.

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