Authorised Therapeutic confirmatory (Phase III) Post-operative nausea and vomiting (PONV)

Postoperative recovery with the addition of long-acting NK1- and 5-HT3 receptor antagonists as prophylaxis for post-operative nausea and vomiting. A prospective, double-blind, randomized trial in laparoscopic surgery.

EU CTIS ID: 2025-522529-36-00

What this study is testing

Is the reduction in QoR-15swe from baseline before surgery to the first postoperative day (POD 1) at least 8.0 points smaller in the intervention group compared to the control group?

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The subject has given their written consent to participate in the trial
  • Adult male or female subjects (>=18 years old)
  • ASA-class I-III
  • Scheduled for elective laparoscopic bariatric surgery or laparoscopic cholecystectomies under general anesthesia
  • Women of Childbearing Capacity (WOCBC) only if pregnancy test is negative or if the woman is using highly effective contraception methods

You likely can't join if

  • Not able to understand and/or cooperative with the study protocol.
  • Documented allergy or intolerance to the IMPs.
  • Psychiatric condition or other reasons that jeopardize compliance with follow up.
  • Breast-feeding females
  • Intestinal obstruction, accessed by anamnesis or clinical findings.
  • Immunosuppressive treatment.
See the full eligibility criteria
Who can join
  • The subject has given their written consent to participate in the trial
  • Adult male or female subjects (>=18 years old)
  • ASA-class I-III
  • Scheduled for elective laparoscopic bariatric surgery or laparoscopic cholecystectomies under general anesthesia
  • Women of Childbearing Capacity (WOCBC) only if pregnancy test is negative or if the woman is using highly effective contraception methods
What rules you out
  • Not able to understand and/or cooperative with the study protocol.
  • Documented allergy or intolerance to the IMPs.
  • Psychiatric condition or other reasons that jeopardize compliance with follow up.
  • Breast-feeding females
  • Intestinal obstruction, accessed by anamnesis or clinical findings.
  • Immunosuppressive treatment.
  • Medication with SSRI or SNRI.
  • Female subjects using anticontraceptive drugs not accepting the need for alternative contraceptive methods for two months (if anticonception is desired by the subject).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.