Safety of adenosine for intracranial aneurysm surgery

JRCT ID: jRCTs061200023

Registered date:22/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: unruptured intracranial aneurysm
• Date of first enrollment: 07/12/2020
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Adenosine-induced hypotension during aneurysmal clipping
Monitoring using electrocardiogram, arterial blood pressure, central venous presssure
Standby transcutaneous pacing in preparation to temporary cardiac arrest
Start of transcutaneous pacing or administration of inotrope in case of prolonged hyptension less than 60mmHg for more than 1 minute

Outcome(s)

• Primary Outcome: modified Rankin Scale (mRS) at 30 days after surgery

Secondary Outcome

1. Completeness of clipping
2. Total doses of adenosine
3. Duration between adenosine administration and clipping
4. mRS at discharge and at 90 days after surgery
5. Prevalence and duration of hypotension by adenosine administration
6. Adverse events caused by adenosine administration
7. Other adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 20 years or older
2. Patients with written informed consent
3. Patients who are planned to receive clipping surgery for unruptured intracranial saccular aneurysm in our institute
4. Cases in which surgeon judged the decompression of aneurysm as effective in clipping

Exclude criteria

1. coronary artery stenosis
2. Past history of ischemic heart disease
3. Aortic valve stenosis
4. Obstructive hypertrophic cardiomyopathy
5. Paroxysmal atrial fibrillation
6. Atrioventricular block
7. Bronchial asthma
8. Chronic obstructive pulmonary disease
9. 80 years or older
10. Pregnant woman, nursing woman
11. Patients who simultaneously receive clipping surgery for multiple aneurysms in one operation
12. Patients who were judged as no interest or having possibility of interruption of assessment of reserach by research responsible physician

Related Information

• Primary Sponsor: HISHIKAWA Tomohito