The Optimal Dose of Mannitol for Intraoperative Brain Relaxation During the Operation of Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT04135456

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-20
• Study Completion Date: 2024-01-14

Brief Summary

Aneurysmal subarachnoid hemorrhage (aSAH) tended to lead to a sudden increase in intracerebral pressure (ICP), which can cause decreased cerebral perfusion and transient global cerebral ischemia. Early clipping and coiling of aneurysms and surgical evacuation of intracerebral hematoma were recommended for aSAH patients. However, the high ICP made it difficult to separate the subarachnoid space during the operation. Effective reduction of ICP was the key to the succession of the operation. But there is a lack of consensus on the management of raised ICP in aSAH. Mannitol is widely used to reduce ICP in patients with cerebral edema. The potential mechanism including decreasing the viscosity of the blood improving regional cerebral microvascular flow and oxygenation and increasing intravascular volume due to increased plasma osmolality. The magnitude of the pressure reduction was correlated with the intact intracranial automatic adjustment function. However, the hypochloremic metabolic alkalosis, hypernatremia, hypokalemia and renal failure associated with mannitol overdose must be considered and the effective dose and the duration of its administration were still unknown. The aims of this study were to determine the most appropriate mannitol dose to provide adequate brain relaxation in aSAH patients with the fewest adverse effects.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Study Design

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

Study Groups

Low dose group

0.5g/kg of 20% mannitol administered at skin incision.

Group Type: EXPERIMENTAL

Mannitol

Intervention Type: DRUG

When the neurosurgeon starts the skin incision, 20% mannitol administered through the venous catheter with fulldrip in 5-10 minutes. Neurosurgeons evaluate the degree of brain relaxation after dura opening in 4 point scale (1=bulging brain, 2=firm brain, 3=satisfactorily relaxed, 4=perfectly relaxed).

Medium dose group

1.0g/kg of 20% mannitol administered at skin incision.

Group Type: EXPERIMENTAL

Mannitol

Intervention Type: DRUG

When the neurosurgeon starts the skin incision, 20% mannitol administered through the venous catheter with fulldrip in 5-10 minutes. Neurosurgeons evaluate the degree of brain relaxation after dura opening in 4 point scale (1=bulging brain, 2=firm brain, 3=satisfactorily relaxed, 4=perfectly relaxed).

High dose group

1.5g/kg of 20% mannitol administered at skin incision.

Group Type: EXPERIMENTAL

Mannitol

Intervention Type: DRUG

When the neurosurgeon starts the skin incision, 20% mannitol administered through the venous catheter with fulldrip in 5-10 minutes. Neurosurgeons evaluate the degree of brain relaxation after dura opening in 4 point scale (1=bulging brain, 2=firm brain, 3=satisfactorily relaxed, 4=perfectly relaxed).

Interventions

Mannitol

When the neurosurgeon starts the skin incision, 20% mannitol administered through the venous catheter with fulldrip in 5-10 minutes. Neurosurgeons evaluate the degree of brain relaxation after dura opening in 4 point scale (1=bulging brain, 2=firm brain, 3=satisfactorily relaxed, 4=perfectly relaxed).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with acute subarachnoid hemorrhage
• Patients who underwent frontal-temporal craniotomy pterional approach aneurysm clipping surgery under general anesthesia.
• Patients operated by the same surgeon (Dr. Chen Xiaolin).

Exclusion Criteria

• Patients who do not agree to the surgery.
• Patients who have congestive heart failure and kidney insufficiency.
• Patients who have pre-operative electrolyte imbalance.
• Patients who did not take the frontotemporal pterygoid approach.
• Patients with contraindications to mannitol due to low blood pressure.
• Patients who have had more than 3 days from bleeding to surgery.
• Patients with intracranial hematoma.
• Patients with Hunt-Hess grades 4-5.
• Patients who received intravenous mannitol within 6 hours before surgery.
• Patients who underwent ventricle puncture and drainage surgery before surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Shuo

Director of Department of Cerebrovascular Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuo Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Xiaolin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

KY 2019-09

Identifier Type: -

Identifier Source: org_study_id