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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05189756
Other study ID # BECD-2-21
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 17, 2022
Est. completion date April 18, 2025

Study information

Verified date May 2023
Source University Hospital Inselspital, Berne
Contact Christian M Beilstein, MD
Phone +41316322111
Email Christian.Beilstein@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. We aim to reduce PONV after laparoscopic bariatric surgery using aprepitant with a similar scheme used for emetogenic chemotherapy.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 224
Est. completion date April 18, 2025
Est. primary completion date March 18, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Aprepitant 80 mg
Encapsulated capsule of aprepitant 80mg to make it look alike to the placebo.
Placebo
Encapsulated placebo capsules for optical, acoustical and haptic blinding.

Locations

Country Name City State
Switzerland Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse Events pre-defined events, safety outcome 3, 24 and 48 hours after surgery, 30 days after surgery
Primary 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. 48 hours
Secondary Severity of nausea mild [NRS 1-3], moderate [NRS 4-6] and severe [NRS 7-10] 3, 24 and 48 hours after surgery
Secondary Incidence of emesis number 3, 24 and 48 hours after surgery
Secondary Use of rescue medication for PONV medication, cumulative dose, route 3, 24 and 48 hours after surgery
Secondary Use of opioid analgesics mg of oral morphine equivalents 3, 24 and 48 hours after surgery
Secondary Use of non-opioid analgesics medication, cumulative dose, route 3, 24 and 48 hours after surgery
Secondary Use of co-analgesics medication, cumulative dose, route 3, 24 and 48 hours after surgery
Secondary Rate of delayed PACU discharge because of PONV number 24 hours after surgery
Secondary Length of PACU stay hours 24 hours after surgery
Secondary Length of hospital stay hours 48 hours after surgery
Secondary Surgical complications at 30 days after surgery using Clavien-Dindo classification (number and grade) 30 days
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