Using dexmedetomidine during surgery for brain aneurysms
Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
This study is testing if giving dexmedetomidine during surgery for brain aneurysms can help protect the brain and improve recovery compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, ElGharbia) |
| Trial ID | NCT06352593 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of intraoperative dexmedetomidine infusion during endovascular interventions for patients with aneurysmal subarachnoid hemorrhage. Aneurysmal subarachnoid hemorrhage is a critical condition that can lead to severe neurological complications, primarily due to cerebral vasospasm. Dexmedetomidine, a selective α-2 adrenergic receptor agonist, is investigated for its neuroprotective properties and ability to improve cerebral perfusion and reduce cellular injury. The study compares the outcomes of patients receiving dexmedetomidine versus a placebo during their surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with unruptured subarachnoid hemorrhage undergoing endovascular intervention.
Not a fit: Patients with subarachnoid hemorrhage from non-aneurysmal causes or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient recovery and reduce neurological complications following aneurysmal subarachnoid hemorrhage.
How similar studies have performed: While the use of dexmedetomidine has shown promise in other contexts, this specific application in aneurysmal subarachnoid hemorrhage is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Tanta, ElGharbia
- Tanta University Hospitals — Tanta, ElGharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.