AuthorisedTherapeutic use (Phase IV)Interventional

Patient-Controlled Anesthesia for endoscopic Procedural Sedation – PCAPS study

When having an endoscopy to check for or remove small growths called adenomas, patients often receive relaxing medicines known as sedation. This study is testing 'patient-controlled sedation'. Instead of the doctor or nurse deciding when to give every dose of relaxing medicine (such as propofol, alfentanil, or midazolam), the patient uses a handset with a button to release small, safe amounts when needed. Researchers want to find out if this approach makes people feel more in control and satisfied with their care. They will also look at how quickly people wake up and recover, how much medication they actually need, and whether the procedure is completed smoothly. The goal is to make routine hospital scopes as comfortable and safe as possible.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Karolinska Institutet

Enrolment target

175

Start

11 Aug 2026

Adenoma

What is this study about?

An endoscopy is a common hospital test where a doctor uses a thin, flexible tube with a camera to look inside your digestive tract. During this procedure, doctors often find and remove small fleshy growths called adenomas (polyps). Removing them helps stop bowel problems from developing later. To keep you comfortable, the medical team usually gives you sedation—medicines that make you feel relaxed, sleepy, and free from pain.

In standard care, the healthcare team decides when and how much sedative to inject into your vein. In this study, doctors are looking at a system called patient-controlled sedation. With this method, you hold a handheld button connected to a smart pump. If you begin to feel uncomfortable or anxious, you press the button to receive a pre-set, safe dose of relaxing medication.

Researchers want to measure how satisfied patients are with this level of control. They will compare it to standard sedation to see if people feel less pain, wake up faster after the test, and experience fewer side effects. Understanding this will help the NHS and hospital teams choose the best ways to keep people comfortable during routine procedures.

Key takeaways

Tests a patient-controlled button for sedation during an endoscopy.
Aims to improve patient comfort, recovery time, and satisfaction.
Uses familiar relaxing medicines like propofol and midazolam.
Takes place during your regular hospital appointment with no extra visits.
Participation is completely optional and does not change your right to standard treatment.

Who may be eligible?

This trial is open to adults aged 18 and over who need an endoscopy to check for or treat adenomas. Both men and women are welcome to take part.

To join, you must be well enough to have planned sedation and able to understand how to use the handheld button device. People who have severe medical conditions that make routine sedation unsafe, or who cannot use a push-button device, may not be able to participate.

Your clinical care team will check your full medical history, your current medicines, and any previous reactions to anaesthetics to ensure this study is completely safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I am scheduled to have an endoscopy to investigate or remove adenomas.
I am medically fit to receive conscious sedation.
I am able to understand and press a handheld button device during my care.

Answer every question to see your result.

What does participation involve?

Taking part in this study happens during your scheduled hospital visit for an endoscopy, so you should not need extra trips to the clinic. Before the test begins, the study team will explain how the patient-controlled pump works and answer all your questions.

During your procedure, you will receive sedation through a small plastic tube (cannula) placed in your arm or hand. Depending on the study group you are in, you may be given the handset to press whenever you feel you need extra comfort. The machine is programmed with safety limits so you cannot give yourself too much medicine.

After your scope is finished, the team will monitor you in the recovery area until you are fully awake. You will be asked to fill out a short questionnaire about how comfortable you felt and your overall experience. Once you have fully recovered and had a light snack, you will be able to go home the same day with a responsible adult.

Potential risks and benefits

You may benefit from feeling more in control of your comfort during the procedure, and the study might help future patients have easier hospital experiences. However, like all sedation, the medications can cause temporary side effects such as drowsiness, light-headedness, mild nausea, or a drop in blood pressure. The clinical team monitors your breathing and heart rate continuously to keep you safe. Joining the study is completely voluntary, and choosing not to take part—or changing your mind at any point—will not affect your standard NHS care in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

Can I give myself an accidental overdose with the button?

No. The pump has a built-in safety 'lockout' timer. Even if you press the button repeatedly, it will only release medicine when it is safe to do so.

Will I be fully asleep during the endoscopy?

Sedation is designed to make you deeply relaxed and drowsy rather than completely unconscious like a general anaesthetic. You may drift off, but you can usually respond to gentle questions.

What is an adenoma?

An adenoma is a common, non-cancerous growth (often called a polyp) inside the bowel. Removing them during an endoscopy prevents them from causing future health issues.

Can I drive myself home after the procedure?

No. Sedation medicines stay in your system for up to 24 hours. You must arrange for an adult to accompany you home and stay with you until the medicines wear off.

What if I do not want to use the button?

Taking part is entirely your choice. If you prefer, you can have standard sedation where the doctor or nurse manages all your medication directly.