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

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ClinicalTrials.gov Identifier: NCT04135456
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Wang Shuo, Beijing Tiantan Hospital

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: Mannitol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Optimal Dosage of Mannitol in Aneurysmal Subarachnoid Hemorrhage Craniotomy
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Mannitol

Arm Intervention/treatment
Experimental: Low dose group
0.5g/kg of 20% mannitol administered at skin incision.
Drug: 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).

Experimental: Medium dose group
1.0g/kg of 20% mannitol administered at skin incision.
Drug: 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).

Experimental: High dose group
1.5g/kg of 20% mannitol administered at skin incision.
Drug: 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).




Primary Outcome Measures :
  1. Brain relaxation score [ Time Frame: Intraoperative ]

    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.



Secondary Outcome Measures :
  1. electrolyte change (potassium) [ Time Frame: before the infusion of mannitol and 30 minutes after the administration of the study drug. ]
    Check the serum laboratory result of potassium (normal range: 3.4-4.5 mmol/L)

  2. electrolyte change (sodium) [ Time Frame: before the infusion of mannitol and 30 minutes after the administration of the study drug. ]
    Check the serum laboratory result of sodium (normal range: 136-146 mmol/L)

  3. electrolyte change (chlorine) [ Time Frame: before the infusion of mannitol and 30 minutes after the administration of the study drug. ]
    Check the serum laboratory result of chlorine (normal range: 98-106 mmol/L)

  4. electrolyte change (calcium) [ Time Frame: before the infusion of mannitol and 30 minutes after the administration of the study drug. ]
    Check the serum laboratory result of calcium (normal range: 1.15-1.29 mmol/L)

  5. Subdural hematoma [ Time Frame: CT scan 6 hours after surgery ]
    Excessive decrease in intracranial pressure may lead to intraoperative or postoperative subdural hematoma formation


Other Outcome Measures:
  1. operation duration [ Time Frame: intraoperative ]
    Poor intracranial pressure reduction may result in prolonged duration of surgery, and evaluation of the duration of surgery is helpful in the selection of the optimal dose.Poor intracranial pressure reduction may result in prolonged duration of surgery, and evaluation of the duration of surgery is helpful in the selection of the optimal dose.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • Patients who does not agree to the surgery.
  • Patients who have congestive heart failure and kidney insufficiency.
  • Patients who have electrolyte imbalance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135456


Contacts
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Contact: Yu Chen, MD +8618801239327 chenyu_tiantan@126.com

Locations
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China, Beijing
Capital Medical University Affiliated Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China
Contact: Yu Chen, MD    +8618801239327    chenyu_tiantan@126.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
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Responsible Party: Wang Shuo, Director of Department of Cerebrovascular Neurosurgery, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04135456    
Other Study ID Numbers: KY 2019-09
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs