Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT06352593

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-06
• Study Completion Date: 2025-10-22

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.

Conditions

Dexmedetomidine; Infusion; Endovascular; Aneurysmal Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group D (Dexmedetomidine)

Patients will be administered Dexmedetomidine 0.5 μg/kg for 10 min and then 0.4 μg/kg/h adjusted to 0.2-0.6 μg/kg/h.

Group Type: EXPERIMENTAL

Intraoperative Dexmedetomidine

Intervention Type: DRUG

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.

Group C (placebo group)

Patients will receive normal saline (control group) .

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients will receive normal saline.

Interventions

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.

Intervention Type: DRUG

Placebo

Patients will receive normal saline.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, ElGharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR557/2/24

Identifier Type: -

Identifier Source: org_study_id