Comparison of General Anesthesia versus High-Flow Nasal Cannula Sedation in Patients with Acute Ischemic Stroke Undergoing Endovascular Treatment

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What is this study about?

This study focuses on patients with acute ischemic stroke, a condition where blood flow to part of the brain is blocked. The research compares two different approaches during a procedure called mechanical thrombectomy, which removes blood clots from brain vessels. One approach uses general anesthesia, while the other uses sedation with a high-flow nasal cannula (a device that delivers oxygen through the nose).

The medications used in the study include lidocaine (a local anesthetic), fentanyl (a pain medication), propofol (an anesthetic medication), rocuronium bromide (a muscle relaxant), and medical oxygen. These medications are given through a vein, except for oxygen which is inhaled. The study aims to determine which approach leads to faster treatment times from hospital arrival to blood flow restoration in the brain.

During the study, patients will receive either general anesthesia with the mentioned medications or sedation with oxygen through a high-flow nasal cannula while doctors perform the clot removal procedure. The doctors will monitor how quickly they can complete the treatment and track the patient’s recovery over time. They will also watch for any complications that might occur during or after the procedure.

1 Initial medical evaluation

Your condition will be assessed as acute ischemic stroke, which is a type of stroke caused by a blood clot in the brain.

Medical staff will evaluate if you meet the criteria, including being at least 18 years old and having specific stroke symptoms.

The treatment must begin within 6 hours from when symptoms started, or within 24 hours if the last time you were seen without symptoms is known.

2 Treatment group assignment

You will be assigned to one of two treatment groups:

Group 1: Treatment with general anesthesia

Group 2: Treatment with sedation and high-flow nasal oxygen

3 Medical procedure

The medical team will perform a mechanical thrombectomy (procedure to remove the blood clot).

If you are in the general anesthesia group, you will receive these medications through an IV line:

– Propofol to induce sleep

– Fentanyl for pain control

– Lidocaine for local pain relief

– Rocuronium for muscle relaxation

If you are in the sedation group, you will receive oxygen through a nasal cannula

4 Follow-up evaluations

After 24 hours: Your condition will be evaluated using a special scale that measures stroke symptoms

The medical team will check for any complications that might have occurred during or after the procedure

After 90 days: Your recovery progress will be assessed using another scale that measures daily function abilities

5 Study completion

The study will track your progress until the final evaluation at 90 days

Your participation will help determine which method leads to faster treatment times for stroke patients

Who Can Join the Study?

Must be 18 years of age or older
Must have a stroke severity score (NIHSS) between 6 and 25 points (NIHSS is a scale used by healthcare providers to measure the severity of a stroke)
Must have a stroke affecting the front part of the brain with blockage in either:
- The internal carotid artery inside the skull (a major blood vessel that supplies blood to the brain)
- The middle cerebral artery in specific segments called M1 or M2 (branches of blood vessels that supply blood to important areas of the brain)
Must arrive at the radiology department either:
- Within 6 hours of when stroke symptoms first started, or
- Within 24 hours of when the person was last seen without symptoms, if brain scans show there is brain tissue that can be saved
Must provide informed consent – either:
- Signed by the patient if they are able to do so
- Signed by a family member or legal representative if the patient is unable to consent

Who Cannot Join the Study?

Age below 18 or above 85 years old
Severe breathing problems or need for immediate airway support
Known allergies to anesthetic medications
Previous stroke in the past 3 months
Uncontrolled high blood pressure (blood pressure above 185/110 mmHg)
Active bleeding anywhere in the body
Blood sugar level below 50 mg/dL or above 400 mg/dL
Pregnancy or breastfeeding
Severe heart problems, including recent heart attack or unstable heart rhythm
Unable to give informed consent and no legally authorized representative available
Participation in another clinical trial within the last 30 days
Current treatment with blood thinners that cannot be reversed
Signs of bleeding in the brain on initial brain scan
Life expectancy less than 6 months due to other medical conditions
History of severe reaction to contrast dye used in medical imaging

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Foydokehv Pfia Lp Isxzkcqeqmkrp Bihuogkht Dfk Hcntmsqu Uuqmmmuhgbipa Le Pvv	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.10.2024

Trial locations

Investigated drugs:

General anesthesia is a type of anesthesia that puts you into a deep sleep during a medical procedure. During general anesthesia, you are completely unconscious and cannot feel pain. It is administered through inhaled gases or intravenous medications.

High-flow nasal cannula (HFNC) is a respiratory support device that delivers warm, humidified oxygen through small tubes placed in your nostrils. It provides comfortable breathing support while keeping you awake and alert. This method is less invasive than general anesthesia and allows you to remain conscious during the procedure.

Both methods are used during mechanical thrombectomy, which is a procedure to remove blood clots in patients with acute ischemic stroke.

Investigated diseases:

Ischaemic stroke

Acute Ischemic Stroke – A condition that occurs when blood flow to an area of the brain is blocked by a blood clot, preventing oxygen and nutrients from reaching brain tissue. It develops suddenly when an artery supplying blood to the brain becomes blocked, typically by a clot that has formed either at the site of blockage or elsewhere in the body and traveled to the brain. The affected brain tissue begins to die within minutes of oxygen deprivation, causing various symptoms depending on which area of the brain is affected. Common signs include sudden weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, and balance difficulties.

Trial ID:

2024-510752-12-00

Protocol code:

GHIFTS

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparison of General Anesthesia versus High-Flow Nasal Cannula Sedation in Patients with Acute Ischemic Stroke Undergoing Endovascular Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?