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 University
Indication
Dexmedetomidine
Indication
Infusion
Indication
Endovascular