Dexmedetomidine Clinical Trial
Official title:
Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University Hospitals | Tanta | ElGharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of vasospasm | Vasospasm is quantified as the percent reduction in arterial diameter between baseline and digital subtraction catheter angiography (DSA). A global assessment of vasospasm will then made and classified as none/mild (0% to 33%), moderate (34% to 66%), or severe (67% to 100%). | 14 days after intervention | |
Secondary | Incidence of morbidity and mortality (M/M) | Morbidity and mortality (M/M) is defined as at least one of the following: death within 6 weeks of subarachnoid hemorrhage (SAH) from any cause; new cerebral infarct within 6 weeks of subarachnoid hemorrhage(SAH) compared with post-procedure computed tomography (CT) scan; delayed ischemic neurological deficit (DIND) due to vasospasm within 14 days of subarachnoid hemorrhage (SAH); and rescue therapy. | 6 weeks after intervention |
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