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

Primary Purpose

Subarachnoid Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mannitol
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Capital Medical University Affiliated Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dose group

Medium dose group

High dose group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

electrolyte change (potassium)
Check the serum laboratory result of potassium (normal range: 3.4-4.5 mmol/L)
electrolyte change (sodium)
Check the serum laboratory result of sodium (normal range: 136-146 mmol/L)
electrolyte change (chlorine)
Check the serum laboratory result of chlorine (normal range: 98-106 mmol/L)
electrolyte change (calcium)
Check the serum laboratory result of calcium (normal range: 1.15-1.29 mmol/L)
Subdural hematoma
Excessive decrease in intracranial pressure may lead to intraoperative or postoperative subdural hematoma formation

Full Information

First Posted
September 11, 2019
Last Updated
February 18, 2020
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04135456
Brief Title
The Optimal Dose of Mannitol for Intraoperative Brain Relaxation During the Operation of Aneurysmal Subarachnoid Hemorrhage
Official Title
Study on the Optimal Dosage of Mannitol in Aneurysmal Subarachnoid Hemorrhage Craniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose group
Arm Type
Experimental
Arm Description
0.5g/kg of 20% mannitol administered at skin incision.
Arm Title
Medium dose group
Arm Type
Experimental
Arm Description
1.0g/kg of 20% mannitol administered at skin incision.
Arm Title
High dose group
Arm Type
Experimental
Arm Description
1.5g/kg of 20% mannitol administered at skin incision.
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
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 Measure Information:
Title
Brain relaxation score
Description
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.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
electrolyte change (potassium)
Description
Check the serum laboratory result of potassium (normal range: 3.4-4.5 mmol/L)
Time Frame
before the infusion of mannitol and 30 minutes after the administration of the study drug.
Title
electrolyte change (sodium)
Description
Check the serum laboratory result of sodium (normal range: 136-146 mmol/L)
Time Frame
before the infusion of mannitol and 30 minutes after the administration of the study drug.
Title
electrolyte change (chlorine)
Description
Check the serum laboratory result of chlorine (normal range: 98-106 mmol/L)
Time Frame
before the infusion of mannitol and 30 minutes after the administration of the study drug.
Title
electrolyte change (calcium)
Description
Check the serum laboratory result of calcium (normal range: 1.15-1.29 mmol/L)
Time Frame
before the infusion of mannitol and 30 minutes after the administration of the study drug.
Title
Subdural hematoma
Description
Excessive decrease in intracranial pressure may lead to intraoperative or postoperative subdural hematoma formation
Time Frame
CT scan 6 hours after surgery
Other Pre-specified Outcome Measures:
Title
operation duration
Description
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.
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. Exclusion Criteria: Patients who does not agree to the surgery. Patients who have congestive heart failure and kidney insufficiency. Patients who have electrolyte imbalance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Chen, MD
Phone
+8618801239327
Email
chenyu_tiantan@126.com
Facility Information:
Facility Name
Capital Medical University Affiliated Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chen, MD
Phone
+8618801239327
Email
chenyu_tiantan@126.com

12. IPD Sharing Statement

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

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