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Study of palonosetron and fosaprepitant to prevent nausea and vomiting after laparoscopic surgery

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This study looks at post-operative nausea and vomiting, which is the feeling of sickness or being sick that can happen after surgery. The study will test whether using two medications called palonosetron and fosaprepitant can help prevent these symptoms in people having keyhole surgery. These medications work by blocking certain signals in the body that cause nausea and vomiting. Some participants will receive these medications while others will receive ondansetron, which is another medication used to prevent sickness. Sodium chloride solution will also be used during the study. The purpose of the study is to find out if adding these longer-acting medications can improve how people feel and recover after their operation.

Participants in this study will be adults who are scheduled to have either weight loss surgery or gallbladder removal surgery performed using keyhole techniques under general anesthesia. Before the surgery, participants will be asked about their overall health and wellbeing. During the operation, they will receive either the study medications or the comparison medication through a vein. After the surgery, participants will be asked to complete questionnaires about how they are feeling, including questions about nausea, vomiting, pain, and their overall recovery. These questions will be asked on the day of surgery and for the following three days while they are in hospital and at home.

The study will also track how much pain medication and anti-sickness medication participants need to use, how long they stay in the recovery area and in hospital, and whether they experience any side effects from the medications such as reactions at the injection site, headache, vision changes, constipation, diarrhea, or tiredness. Any complications that occur up to thirty days after surgery will be recorded. Some participants will also be invited to take part in interviews between one and three months after their surgery to talk about their experience of recovering from the operation.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Providing written consent and initial screening
Your participation begins when you provide your written consent to take part in the trial.
Your medical history will be reviewed to confirm that you meet the requirements for participation.
If you are a woman of childbearing potential, a pregnancy test will be performed to ensure the result is negative, or you must be using highly effective methods to prevent pregnancy.
Step 2
Baseline assessment before surgery
Before your surgery, you will complete a questionnaire called QoR-15swe, which measures your quality of recovery and overall well-being.
This questionnaire serves as your baseline measurement, which will be compared to your responses after the surgery.
Step 3
Surgery and medication administration
You will undergo your scheduled laparoscopic surgery under general anesthesia.
During or around the time of your surgery, you will receive one of the following medication combinations through an intravenous line, depending on which group you are randomly assigned to:
The intervention group receives palonosetron and fosaprepitant, which are long-acting medications designed to prevent nausea and vomiting after surgery. These medications block specific receptors in the body that trigger these symptoms.
The control group receives ondansetron or sodium chloride solution, which are standard treatments or placebo used for comparison.
All medications are administered as an intravenous injection or infusion.
This is a double-blind trial, meaning neither you nor your medical team will know which treatment you receive during the trial.
Step 4
Recovery in the post-anesthesia care unit
After your surgery, you will be taken to the post-anesthesia care unit (PACU), where you will be monitored as you wake up from anesthesia.
During your time in the PACU, you will be asked about any feelings of nausea (feeling sick to your stomach) or episodes of vomiting.
Your pain level will be assessed using a numerical rating scale (NRS), where you will rate your pain from 0 (no pain) to 10 (worst pain imaginable).
If you experience nausea or vomiting, you may receive additional anti-nausea medications as needed.
The length of time you spend in the PACU will be recorded.
You will also complete the QoR-15swe questionnaire on the day of surgery (POD0).
Step 5
Hospital stay and monitoring
During your hospital stay, you will continue to be monitored for any episodes of nausea or vomiting.
Your pain levels will be assessed regularly using the numerical rating scale.
Any additional anti-nausea medications you receive will be recorded.
You will be observed for potential side effects of the trial medications, including reactions at the injection site, headache, visual disturbances, constipation, diarrhea, and tiredness.
The total length of your hospital stay until discharge will be recorded.
Step 6
First day after surgery assessment
On the first postoperative day (POD1), you will complete the QoR-15swe questionnaire again.
This measurement is the primary focus of the trial and will be compared to your baseline assessment before surgery.
Step 7
Home recovery monitoring through day three
After you are discharged from the hospital, you will continue to monitor your recovery at home through the third postoperative day (POD3).
You will be asked to report any episodes of nausea or vomiting that occur at home.
You will record your pain levels using the numerical rating scale.
You will document any anti-nausea medications you take at home.
You will complete the QoR-15swe questionnaire on the second postoperative day (POD2) and the third postoperative day (POD3).
You will continue to note any side effects such as headache, visual disturbances, constipation, diarrhea, or tiredness.
Step 8
Thirty-day follow-up for complications
From the day of surgery through thirty days after surgery (POD30), any complications that occur will be documented and classified according to the Clavien-Dindo system, which is a standardized way of grading surgical complications.
Step 9
Qualitative interview about your experience
Between 30 and 90 days after your first visit, you may be invited to participate in an interview about your postoperative recovery experience.
This interview will explore your personal experiences and perspectives on recovering from surgery.
The information gathered will be analyzed to identify common themes and insights into patient recovery experiences.

Who can join the trial?

5 criteria

You must provide your written consent to take part in the trial, which means you agree in writing to participate after understanding what the study involves
You must be an adult, meaning you are 18 years old or older
You must have an ASA-class I-III, which is a rating system doctors use to describe your overall health status before surgery, where class I means you are healthy, class II means you have mild health problems, and class III means you have more serious but controlled health conditions
You must be scheduled for a planned surgery that is either laparoscopic bariatric surgery, which is weight loss surgery done through small cuts using a camera and special tools, or laparoscopic cholecystectomy, which is gallbladder removal surgery done through small cuts, and the surgery must be done under general anesthesia, which means you will be completely asleep during the procedure
If you are a woman who can become pregnant, you must either have a negative pregnancy test or be using highly effective contraception methods, which are birth control methods that are very reliable at preventing pregnancy

Who cannot join the trial?

2 criteria

The study has not provided specific exclusion criteria, which are conditions or situations that would prevent you from taking part in this research
You should discuss with the research team whether you are suitable to participate in this study

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Region Vaesterbotten
Umea, Sweden

Trial locations

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Investigated drugs

NK1 receptor antagonist
is a medication used to prevent nausea and vomiting after surgery. It works by blocking certain signals in your brain that trigger the feeling of nausea. This is a long-acting medication, which means it continues to work for an extended period after you receive it.
5-HT3 receptor antagonist
is another medication used to prevent nausea and vomiting after surgery. It works differently from the NK1 antagonist by blocking a different type of signal in your body that causes nausea. Like the NK1 antagonist, this is also a long-acting medication that provides protection against nausea for a longer time.

What is already known about the treatment

NK1 receptor antagonist
This medication is given to prevent nausea and vomiting after surgery by blocking a specific protein in the brain called the NK1 receptor, which is involved in triggering the vomiting reflex. It belongs to a class of drugs known as antiemetics, which are specifically designed to stop or reduce feelings of sickness. The long-acting version used in this trial provides extended protection during the recovery period following laparoscopic surgery. This type of medication is widely recognized in medical practice as an effective option for preventing post-operative nausea and vomiting.
5-HT3 receptor antagonist
This medication works by blocking serotonin receptors in the brain and digestive system that are responsible for triggering nausea and vomiting after surgical procedures. It is classified as an antiemetic drug and is commonly used to prevent post-operative sickness in patients undergoing various types of surgery. The long-acting formulation tested in this clinical trial provides prolonged relief during the critical recovery hours following laparoscopic operations. These medications are well-established in modern medicine as a standard preventive treatment for patients at risk of experiencing nausea and vomiting after anesthesia and surgery.

Investigated diseases

Postoperative Nausea and Vomiting – Postoperative nausea and vomiting is a common complication that occurs after surgical procedures and anesthesia. It typically develops within the first 24 hours following surgery, though it can persist for several days. The condition involves feelings of nausea, which is the unpleasant sensation of needing to vomit, and actual vomiting episodes. Multiple factors can contribute to its development, including the type of anesthesia used, the duration and nature of the surgery, and individual patient characteristics. The symptoms can significantly affect a patient's comfort and recovery process after surgery. While it usually resolves within a few days as the effects of anesthesia wear off and the body recovers from surgery, it can impact the patient's ability to eat, drink, and participate in early recovery activities.