Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage

Tanta University

Status: Completed

Conditions: Endovascular; Dexmedetomidine; Aneurysmal Subarachnoid Hemorrhage; Infusion

Treatments: Other: Placebo; Drug: Intraoperative Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06352593

36264PR557/2/24

Details and patient eligibility

About

The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.

Full description

Aneurysmal subarachnoid hemorrhage is a sudden, life-threatening emergency caused by bleeding in the subarachnoid space between the brain and skull. Cerebral vasospasm (VSP) is the leading risk factor of neurological deterioration (i.e., delayed cerebral ischemia [DCI] and cerebral infarction) after aneurysmal subarachnoid hemorrhage (SAH) and a cause of morbidity and mortality.

Dexmedetomidine (DEX) is a highly selective α-2 adrenergic receptor agonist. The α -2 receptor agonists have a long track record of use for sedation and analgesia. It has been shown that α -2 agonists are neuroprotective in craniocerebral and subarachnoid injuries. Dexmedetomidine has a significant effect on the central nervous system and decreases the blood flow in the brain and the requirement or needs for cerebral oxygen. It also modifies memory and enhances cognitive ability effects like sedation, analgesic, and anxiolytics. Dexmedetomidine is shown to decrease catecholamine in the brain and improves the perfusion ability in the penumbra. The glutamate level is significantly reduced by Dexmedetomidine (DEX), and so injuries at the cellular level is reduced.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >18 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) I-III
• Unruptured subarachnoid hemorrhage (SAH) confirmed by digital subtraction catheter angiography (DSA) undergoing endovascular intervention with general anesthesia.

Exclusion criteria

• Subarachnoid hemorrhage (SAH) from a lesion other than a ruptured saccular aneurysm.
• Intraventricular or intracerebral blood in the absence of localized thick or diffuse Subarachnoid hemorrhage (SAH).
• No or localized thin subarachnoid hemorrhage (SAH) on computed tomography (CT).
• Cerebral vasospasm on admission digital subtraction catheter angiography (DSA).
• Hypotension (systolic blood pressure 90 mm Hg) refractory to fluid therapy.
• Neurogenic pulmonary edema.
• Cardiac failure requiring inotropic support.
• Severe or unstable concomitant condition or disease or chronic condition.
• Kidney and/or liver disease.
• Prior cerebral damage on computed tomography (CT) scan such as stroke (>2 cm maximum diameter).
• Pregnancy.
• Traumatic brain injury.
• Previously treated cerebral aneurysm.
• Arterial venous malformation.
• Pre-existing cerebrovascular disorder that will affect diagnosis and evaluation of Subarachnoid hemorrhage (SAH).
• Ischemic heart disease or second or third-degree atrioventricular block.
• Long-term abuse of alcohol, opioids, or sedative-hypnotic drugs.
• Obesity (body mass index [BMI] >30 kg/m2).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Group D (Dexmedetomidine)

Experimental group

Description:

Patients will be administered Dexmedetomidine 0.5 μg/kg for 10 min and then 0.4 μg/kg/h adjusted to 0.2-0.6 μg/kg/h.

Treatment:

Drug: Intraoperative Dexmedetomidine

Group C (placebo group)

Placebo Comparator group

Description:

Patients will receive normal saline (control group) .

Treatment:

Other: Placebo