Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Global Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion for Induction of General Anesthesia in Adults Undergoing Elective Surgery

This study is looking into a new medicine called HSK3486, which is given as a drip to help people fall asleep for surgery. It’s a ‘Phase 3’ study, meaning it's one of the final steps before a new medicine might become available more widely. Researchers want to check if this new medicine is as good as, or better than, a standard anaesthetic called propofol for safely putting adults to sleep for operations. They'll be watching closely to see how quickly and smoothly people go to sleep, how well they stay asleep during surgery, and if there are any side effects, especially around the injection site. This research aims to find safer and more effective ways to help you go to sleep before an operation.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Haisco-USA Pharmaceuticals Inc.

Enrolment target

140

Start

12 Feb 2024

General anaesthesia

What is this study about?

This research study is focused on improving how we help adults go to sleep for general anaesthesia before surgery. General anaesthesia is the special sleep you're put into so you don't feel pain during an operation. The study is testing a new medicine called HSK3486 that's given as a liquid through a drip. It's being compared to a widely used medicine called propofol, which is a common way to start anaesthesia.

The main goal is to see how well HSK3486 works to put someone to sleep smoothly and safely. Researchers will be looking to see if patients go to sleep successfully without needing too many extra doses of medication. They will also be checking if patients remain asleep at the right level during surgery and if the medicine affects their breathing or heart too much. Safety is very important, so they will also be monitoring for any side effects, particularly pain where the injection is given.

By comparing this new medicine to an existing one, the study hopes to find out if HSK3486 could be a good new option for doctors to use for general anaesthesia. This could potentially lead to more choices for patients and doctors, perhaps offering a medicine with different benefits or fewer side effects for certain individuals needing surgery.

Key takeaways

This study evaluates a new anaesthetic given via injection for adults.
It compares the new medicine to a standard anaesthetic before surgery.
The main goals are to check how well it works and if it's safe.
All participants (and doctors) are 'blinded' to which medicine is given.
Participation could help develop new anaesthesia options for the future.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 years or older. Both men and women are welcome to take part.

Since this study is about general anaesthesia for operations, you would need to be scheduled for an elective surgery. An elective surgery is one that is planned in advance, rather than an emergency.

There might be other health conditions or medications that mean you can't take part, even if you fit these basic requirements. The study doctors will carefully check your full medical history to make sure it's safe for you to join.

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 for a planned (elective) surgery?
Are you available to participate regardless of your gender (male or female)?
Are you generally healthy enough to be considered for an operation requiring general anaesthesia?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine (either the new drug or the standard one) as an injection to help you go to sleep for your planned operation. Doctors and nurses would carefully monitor you throughout your surgery and afterwards to see how you respond to the anaesthesia.

They would check how quickly you fall asleep, how well you stay asleep, and how you wake up. They'd also keep a close eye on your vital signs like your heart rate and breathing, and ask you about any pain, especially around the injection site. There would be follow-up checks after your surgery, but these would largely be part of your normal recovery process, with specific study-related questions or checks added in. The total time you'd be involved in the study would depend on your recovery, but the main part concerning the anaesthesia would be around your surgery day.

Potential risks and benefits

Taking part in any medical study always has potential benefits and risks. A potential benefit of taking part in this study is contributing to medical knowledge that could lead to new, possibly safer or more effective, options for general anaesthesia in the future. You would also receive very close medical monitoring during and after your surgery. Potential risks might include side effects from the study medication, which could be similar to those of standard anaesthetics, such as nausea or injection site discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Poland

Common questions

What is 'general anaesthesia'?

General anaesthesia is a special type of sleep induced by medicines, so you don't feel pain or remember anything during an operation.

What does 'Phase 3' mean for a study?

Phase 3 means this is one of the final stages of testing a new medicine. It means the medicine has already shown promise in earlier tests and is now being compared to existing treatments in a larger group of people.

Will I know if I'm getting the new medicine or the standard one?

No, this is a 'double-blinded' study, meaning neither you nor your doctors will know which medicine you're receiving. This helps make the study results fair and accurate.

What is an 'elective surgery'?

An elective surgery is an operation that is planned in advance, rather than an emergency. Examples include hip replacements or gallbladder surgery.

Will this study affect my usual surgical care?

No, your medical care for the surgery will not be affected. You will receive either the new study medicine or a standard, approved anaesthetic, and your surgical team will continue to provide the best possible care for you.