AuthorisedPhase II and Phase III (Integrated)Interventional

Evaluation of the effect of Opioid-Free Anesthesia on oxygenation in bariatric surgery

This research is investigating a new way to give anaesthesia for weight-loss surgery. Instead of using traditional painkillers called opioids during the operation, doctors are trying an 'opioid-free' approach. The main goal is to see if this new method helps patients maintain better oxygen levels in their blood during the first six hours after surgery. They're comparing it with the usual anaesthesia to find out if it's more effective. This study aims to make surgery safer and recovery smoother for people having weight-loss procedures. Doctors are hoping to improve how well patients breathe and recover after their operation.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Enrolment target

Start

20 Nov 2024

bariatric surgery

What is this study about?

When you have an operation, you'll need anaesthesia to make sure you don't feel any pain. This study is looking at a specific type of anaesthesia called 'opioid-free anaesthesia' for people having weight-loss surgery. 'Opioid-free' simply means that the doctors won't use certain strong painkillers called opioids during your operation.

The main aim of this research is to see how this opioid-free approach affects your oxygen levels. Good oxygen levels are very important, especially after surgery. The doctors want to find out if this new type of anaesthesia helps you get enough oxygen in the first few hours after your weight-loss operation compared to the usual anaesthesia patients receive.

By comparing these two methods, researchers hope to discover if opioid-free anaesthesia could lead to better breathing and a smoother recovery for people having weight-loss surgery. The results could help doctors decide the best way to keep patients comfortable and safe during and after their procedures.

Key takeaways

This study compares two types of anaesthesia for weight-loss surgery.
It aims to see if 'opioid-free' anaesthesia improves oxygen levels after surgery.
Participation involves receiving one of two anaesthesia types during your planned operation.
Researchers will monitor your oxygen levels for 6 hours after surgery.
Adults aged 18 and over, both men and women, are eligible if having weight-loss surgery.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, which means people of all adult ages can be considered. Both men and women are welcome to participate in this research.

Since the study focuses on weight-loss surgery, you would need to be scheduled for this type of operation to be considered for inclusion. The medical team will check other details from your medical history to make sure the study is a good fit for you and safe for your health.

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 18 years old or older?
Are you scheduled to have weight-loss (bariatric) surgery?
Are you comfortable with potentially receiving either the new or standard anaesthesia?
Are you willing to have your oxygen levels monitored for 6 hours after surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the opioid-free anaesthesia or the standard anaesthesia during your scheduled weight-loss surgery. The type of anaesthesia you receive would be decided randomly, like flipping a coin. The researchers would then closely monitor your oxygen levels for the first six hours after your surgery.

This involves taking regular measurements of your blood oxygen during this period. You would also have routine checks by the medical team as part of your normal post-surgery care. There are no extra visits or long-term follow-up beyond what is usually required after your operation. The total duration of your participation would mainly be focused on the anaesthesia during your surgery and the immediate 6-hour period afterwards.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the opioid-free anaesthesia might lead to better oxygen levels and a smoother recovery after your weight-loss surgery, although this is what the study is trying to find out. A potential risk is that, like any anaesthesia, there can be side effects, though the study aims to use commonly available medications like Ketolar (ketamine) which are already used in medical practice. You will be closely monitored, and your care team will be there to address any concerns. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is 'opioid-free anaesthesia'?

It's a way of giving you anaesthesia during surgery without using certain strong painkillers called opioids. Doctors use other medicines instead to keep you comfortable.

Why are researchers studying this?

They want to see if avoiding opioids during weight-loss surgery can help patients maintain better oxygen levels and potentially have a smoother recovery.

Will I know if I'm getting the new anaesthesia or the usual one?

No, it's usually decided randomly, like drawing lots. This helps make the study fair and scientific. You will receive one of the two types of anaesthesia.

What is Ketolar?

Ketolar is a brand name for a medicine called ketamine. It's an anaesthetic that can be used in surgery and is being tested as part of the opioid-free approach.

Will this change my weight-loss surgery plan?

No, the study focuses on the type of anaesthesia you receive during your planned surgery, not on the surgery itself. Your surgeon will proceed with your chosen weight-loss procedure.