DexmedetomidineNCT06352593
Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage
A study testing Intraoperative Dexmedetomidine in people with Dexmedetomidine and Infusion, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexmedetomidine, Infusion, Endovascular
- What is being tested?
- Intraoperative Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Intraoperative Dexmedetomidine, Placebo
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative DexmedetomidineDrug
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.
PlaceboOther
Patients will receive normal saline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intraoperative Dexmedetomidine |
| Group C (placebo group) | Placebo comparator | Patients will receive normal saline (control group) . Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 14 days after intervention
Secondary outcomes (1)
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.
Measured: 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start6 Apr 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352593
- Sponsor's protocol ID
- 36264PR557/2/24
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06352593
- Acronym / sponsor ID
- 36264PR557/2/24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Dexmedetomidine) | Experimental | Drug: Intraoperative DexmedetomidinePatients 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 C (placebo group) | Placebo comparator | Other: PlaceboPatients will receive normal saline (control group) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative DexmedetomidinePatients 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. | Drug | Group D (Dexmedetomidine) |
| PlaceboPatients will receive normal saline. | Other | Group C (placebo group) |
Primary outcome
Incidence of vasospasm
Time frame: 14 days after intervention
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%).
1 secondary outcome
Incidence of morbidity and mortality (M/M)
Time frame: 6 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Dexmedetomidine in people with Dexmedetomidine and Infusion, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vasospasm (time frame: 14 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.