Clinical trial NCT06352593: Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage
Official title: Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Infusion
Endovascular
Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of vasospasm
timeFrame: 14 days after intervention
Secondary outcomes:
measure: Incidence of morbidity and mortality (M/M)
timeFrame: 6 weeks after intervention
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbia
Study officials:
References: