Clinical trial
Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
Name
36264PR557/2/24
Description
The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.
Trial arms
Trial start
2024-04-06
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Recruiting
Treatment
Intraoperative Dexmedetomidine
Patients will be administered DEX 0.5 μg/kg for 10 min and then 0.4 μg/kg/h adjusted to 0.2-0.6 μg/kg/h.
Arms:
Group D (Dexmedetomidine)
Placebo
Patients will receive normal saline.
Arms:
Group C (placebo group)
Size
90
Primary endpoint
Incidence of vasospasm
14 days after intervention
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-04-09
1 organization
1 product
4 indications
Organization
Tanta UniversityProduct
DexmedetomidineIndication
DexmedetomidineIndication
InfusionIndication
EndovascularIndication
Subarachnoid Hemorrhage (Aneurysmal)