Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage

NCT06352593 | Completed

• 1 other identifier: 36264PR557/2/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.

Conditions

Dexmedetomidine; Infusion; Endovascular; Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of morbidity and mortality (M/M)

  6 weeks after intervention

Study Arms (2)

Group D (Dexmedetomidine)

EXPERIMENTAL

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.

Drug: Intraoperative Dexmedetomidine

Group C (placebo group)

PLACEBO COMPARATOR

Patients will receive normal saline (control group) .

Other: Placebo

Interventions

Intraoperative Dexmedetomidine 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 D (Dexmedetomidine)

Placebo OTHER

Patients will receive normal saline.

Group C (placebo group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 6, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)