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

NCT04135456 | Unknown Phase 1

• 1 other identifier: KY 2019-09
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Brain relaxation score

  The degree of brain relaxation after administration was assessed as four grades. denoting bulging or the condition that additional methods for brain relaxation are immediately and always required in order to continue the surgical procedure because of brain swelling; firm or the condition that additional methods for brain relaxation are occasionally required to continue the surgical procedure; adequate; perfectly relaxed. All patients received conventional frontotemporal pterional approach, and the time from skin incision to dural opening was constant for 30 minutes. At the time of dural opening, the degree of cerebral relaxation was evaluated, and the satisfactory cerebral relaxation was defined as 3 or 4 points.

  Intraoperative

Secondary Outcomes (6)

• electrolyte change (potassium)

  before the infusion of mannitol and 30 minutes after the administration of the study drug.

• electrolyte change (sodium)

  before the infusion of mannitol and 30 minutes after the administration of the study drug.

• electrolyte change (chlorine)

  before the infusion of mannitol and 30 minutes after the administration of the study drug.

• electrolyte change (calcium)

  before the infusion of mannitol and 30 minutes after the administration of the study drug.

• Subdural hematoma

  CT scan 6 hours after surgery

Other Outcomes (1)

• operation duration

  intraoperative

Study Arms (3)

Low dose group

EXPERIMENTAL

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

Drug: Mannitol

Medium dose group

EXPERIMENTAL

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

Drug: Mannitol

High dose group

EXPERIMENTAL

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

Drug: Mannitol

Interventions

Mannitol 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; Low dose group; Medium dose group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Mannitol

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

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Shuo Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Xiaolin Chen, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: October 22, 2019
• Study Start: April 20, 2019
• Primary Completion: November 14, 2023
• Study Completion: January 14, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

CN (1)