RecruitingPHASE4INTERVENTIONAL

Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.

This study is investigating a new approach to managing pain during and after surgery. It focuses on patients undergoing specific abdominal surgeries, like hysterectomies or left hemicolectomies. Researchers want to see if using a drug called esmolol, which affects heart rate, alongside a special pain monitoring system, can reduce the amount of strong pain relievers (opioids) needed during the operation. They also want to check if this combination helps lower pain levels in the hours after surgery. The aim is to find ways to manage pain effectively with fewer side effects associated with traditional strong pain medications.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrolment target

Start

16 Apr 2024

Estimated completion

04 Mar 2025

Opioid Use, Unspecified Anesthesia Nociceptive Pain

What is this study about?

This study, called 'Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception,' is looking for better ways to manage pain during and after certain surgeries. When you have an operation, doctors give you medication to control pain, often strong pain relievers called opioids. While these are good at keeping you comfortable, they can sometimes cause unwanted side effects like feeling sick, itching, or breathing problems. There's also a growing concern about the long-term use of opioids.

This research is exploring two strategies working together. The first involves a medication called esmolol, which is a short-acting drug used to control heart rate and blood pressure. It's thought that esmolol can help reduce pain signals your body sends during surgery, potentially meaning you need less of the strong pain relief. The second strategy uses a special monitor that measures your body's response to pain during the operation. This helps doctors give you just the right amount of pain medication you need.

The main goal is to see if combining esmolol with this special pain monitoring system can cut down on the amount of strong pain medication (like remifentanil) patients need during surgery. They'll also be checking if this approach leads to less pain in the recovery room after the operation. By finding ways to use less strong pain medication while still keeping you comfortable, doctors hope to reduce the side effects and risks associated with these drugs.

Key takeaways

This study explores new ways to manage pain during and after surgery.
It combines a heart medication (esmolol) with special pain monitoring.
The goal is to reduce the amount of strong pain relievers (opioids) needed.
It focuses on adults having specific abdominal keyhole surgeries.
You will be closely monitored if you participate.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old. You must be having specific types of keyhole (laparoscopic) surgery that also involve a small cut below the belly button. This includes operations like a hysterectomy (womb removal, but not through the vagina) or a left hemicolectomy (a type of bowel surgery). The operation should also be expected to last less than three hours.

You cannot be in this study if you have certain health conditions that would make esmolol, one of the study drugs, unsafe for you. This includes problems like very low blood pressure, certain heart conditions (like a very slow heartbeat, specific heart blockages, or severe heart failure), untreated high blood pressure due to a specific gland issue, or severe kidney problems. Also, if you have breathing conditions like asthma or severe lung disease, or conditions affecting blood flow in your arms and legs like Raynaud's disease, you wouldn't be able to join.

You also can't participate if you have severe memory or thinking problems, if you regularly use strong pain medications (opioids) or certain heart medications (beta-blockers) before the study, or if there's a high chance your keyhole surgery might need to be switched to a large open surgery. If during the study your keyhole surgery does get changed to a large open surgery, or if you decide you no longer want to participate, you will be withdrawn.

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.

Are you between 18 and 65 years old?
Are you having a specific type of keyhole abdominal surgery (like a hysterectomy or left hemicolectomy with a small lower cut)?
Do you have any serious heart conditions, breathing problems, or other health issues that might make esmolol unsafe for you?
Are you currently taking strong pain medications (opioids) or certain blood pressure medications (beta-blockers) regularly?
Do you have any known allergies to beta-blocker medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will begin once you are scheduled for surgery. During your surgery, while you are under general anaesthesia, you will be randomly assigned to either receive the study drug esmolol through a drip, or a saltwater solution (placebo) through a drip. The exact amount of strong pain relief medication (remifentanil) you receive during surgery will be guided by a special pain monitor. After your surgery, the researchers will check your pain levels in the recovery room. The full duration of your direct participation in the study will mostly revolve around your day of surgery and immediate recovery period, as decisions about medication are taken during the operation and pain levels are measured afterwards.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving less strong pain medication during and after surgery, which could reduce common side effects like nausea or itching. However, as with any medical procedure or medication, there are always potential risks. Esmolol, the study drug, can have side effects related to your heart rate and blood pressure, and these will be carefully monitored. You will be closely watched by the medical team throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
Verified postcode
Montreal East, Canada· Recruiting

Common questions

What is esmolol?

Esmolol is a type of medication called a beta-blocker that helps slow down your heart rate and lower your blood pressure, and it's used in this study to see if it helps with pain.

What is the Nociception Level Index?

It's a special monitor that helps doctors understand an individual's pain levels during surgery, so they can give just the right amount of pain medication.

Will I still get pain medication during surgery?

Yes, you will still receive general anaesthesia and pain medication like remifentanil, but the study aims to see if less is needed.

Will I know if I'm getting esmolol or a dummy solution?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving until after the study is complete, to ensure fair results.

What kind of surgeries are included?

The study focuses on certain keyhole (laparoscopic) surgeries of the tummy, like hysterectomy (womb removal) or left hemicolectomy (a bowel operation), that also involve a small cut below the belly button.

How to find out more

Pascal Laferrière-Langlois

pascal.laferriere-langlois@umontreal.ca +1-819-432-5847 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.