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Study on Aprepitant for Preventing Nausea and Vomiting After Bariatric Surgery in Patients

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a medication called aprepitant in preventing postoperative nausea and vomiting (PONV) after bariatric surgery. Bariatric surgery is a type of surgery that helps with weight loss by making changes to the digestive system. PONV is a common issue that can occur after surgery, causing discomfort and delaying recovery. The trial aims to see if aprepitant can reduce the occurrence of nausea and vomiting after these surgeries.

Participants in the study will receive either aprepitant or a placebo, which is a substance with no active medication. The study will observe the effects of aprepitant on patients undergoing different types of bariatric surgery, such as laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis mini gastric bypass. The trial will monitor the incidence and severity of PONV, as well as the need for additional medication to manage symptoms.

The study will also look at other factors, such as the length of stay in the recovery room and overall hospital stay, as well as patient satisfaction with their postoperative experience. By understanding how aprepitant affects these outcomes, the trial hopes to improve the recovery process for patients undergoing bariatric surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as being scheduled for bariatric surgery, being 18 years or older, having a body mass index (BMI) over 30, and having at least two risk factors for postoperative nausea and vomiting (PONV).
Step 2
Pre-surgery preparation
Before surgery, the patient receives a medication called aprepitant. This medication is administered in the form of a hard capsule. The dosage is 125 mg taken orally.
Step 3
Surgery day
On the day of surgery, the patient undergoes the scheduled bariatric procedure, which could be laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis mini gastric bypass.
Step 4
Post-surgery medication
After surgery, the patient continues to take aprepitant to help prevent nausea and vomiting. The dosage is 80 mg, taken orally as a hard capsule.
Step 5
Monitoring and assessment
The patient is monitored for the incidence and severity of PONV using scales such as the numeric rate scale (NRS) and Rhodes scale. The use of any additional medication to manage symptoms is also recorded.
Step 6
Recovery and discharge
The length of stay in the recovery room and the overall hospital stay are documented. Patient satisfaction with the postoperative period is assessed using a subjective scale from 1 to 10.

Who can join the trial?

4 criteria

The patient is scheduled for **bariatric surgery**, which includes procedures like **LSG (laparoscopic sleeve gastrectomy)**, **RYGB (Roux-en-Y gastric bypass)**, or **OAGB (one-anastomosis MINI gastric bypass)**. These are types of weight-loss surgeries.
The patient is an adult, meaning they are **18 years or older**.
The patient has at least **2 risk factors** for **PONV (postoperative nausea and vomiting)**. These risk factors include being female, not smoking, using pain relief medication called **opioids** after surgery, having experienced PONV before, and having a surgery that lasts longer than **1 hour**.
The patient has **obesity**, which means having a **BMI (Body Mass Index)** of more than **30**. BMI is a measure that uses height and weight to estimate body fat.

Who cannot join the trial?

4 criteria

Individuals who are not experiencing postoperative nausea and vomiting cannot participate. This means if you do not feel sick or vomit after surgery, you are not eligible.
Participants must be within certain age ranges. If you are not in the specified age group, you cannot join the study.
Both males and females can participate, but if you do not identify as either, you may not be eligible.
If you belong to a group considered vulnerable, such as those with certain health conditions or disabilities, you may not be able to participate.

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Investigated drugs

Aprepitant is a medication used in this trial to prevent nausea and vomiting after surgery. It works by blocking certain signals in the brain that trigger nausea and vomiting, helping patients feel more comfortable after their procedure.

Aprepitant

What is already known about the treatment

Aprepitant – Aprepitant is administered orally in capsule form. It is currently recognized in medical literature as an effective medication for preventing nausea and vomiting, particularly after surgery. The main therapeutic indication for aprepitant is to reduce the incidence of postoperative nausea and vomiting. At the molecular level, aprepitant works by blocking the neurokinin-1 (NK1) receptors in the brain, which are involved in the vomiting reflex. It is classified pharmacologically as a neurokinin-1 receptor antagonist.

Investigated diseases

Postoperative Nausea and Vomiting – This condition occurs after surgery and is characterized by feelings of nausea and episodes of vomiting. It is a common complication following anesthesia and surgical procedures. The symptoms can vary in intensity and duration, often starting shortly after the operation and potentially lasting for several hours or days. Factors such as the type of surgery, anesthesia used, and individual patient characteristics can influence its occurrence. The condition can lead to discomfort and may affect the recovery process. Management typically focuses on alleviating symptoms and improving patient comfort.