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Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

Primary Purpose

Brain Neoplasms, Surgery, Hyperemia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial Doppler (TCD)
jugular venous bulb catheterization
Tumor removal surgery under general anesthesia
Radial artery catheterization
Abdominal surgery under general anesthesia
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Neoplasms focused on measuring Cerebral blood flow, Transcranial Doppler, Emergence from general anesthesia

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesia (ASA) physical status I or II
  • Scheduled for selective supratentorial tumor removal surgery or major abdominal surgery.

Exclusion Criteria:

  • Patients with evidence of systemic hypertension, intracranial hypertension, cerebrovascular diseases, other coexisting medical conditions likely to affect cerebral autoregulation.
  • Preoperatively planned delayed tracheal extubation.
  • Pregnant or nursing women

Sites / Locations

  • Huashan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients undergoing craniotomy

Patients undergoing abdominal surgery

Arm Description

Patients undergoing craniotomy who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited. Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.

Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler (TCD) measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.

Outcomes

Primary Outcome Measures

Mean Blood Flow Velocity in Middle Cerebral Artery
It was the baseline mean blood flow velocity in middle cerebral artery.
Mean Blood Flow Velocity in Middle Cerebral Artery
Mean Blood Flow Velocity in Middle Cerebral Artery
Mean Blood Flow Velocity in Middle Cerebral Artery
Mean Blood Flow Velocity in Middle Cerebral Artery
Mean Blood Flow Velocity in Middle Cerebral Artery
Oxygen Saturation of Jugular Venous Bulb
Oxygen Saturation of Jugular Venous Bulb
Oxygen Saturation of Jugular Venous Bulb
Oxygen Saturation of Jugular Venous Bulb
Oxygen Saturation of Jugular Venous Bulb
Oxygen Saturation of Jugular Venous Bulb

Secondary Outcome Measures

Full Information

First Posted
July 8, 2012
Last Updated
May 15, 2013
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01642147
Brief Title
Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy
Official Title
Cerebral Hyperemia During Emergence From General Anesthesia for Craniotomy of Patients With Brain Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Few studies look into cerebral blood flow (CBF) changes during emergence from general anesthesia for craniotomy. The purpose of this study is to demonstrate CBF changes during emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation of jugular vein bulb and transcranial Doppler.
Detailed Description
30 patients undergoing selective craniotomy (craniotomy group) for supratentorial brain tumor removal and 30 patients undergoing selective abdominal surgery (abdominal surgery group) are planned to be enrolled in the study. Mean blood flow velocity in middle cerebral artery (Vmca), mean arterial pressure (MAP), blood oxygen saturation of jugular vein bulb (SjvO2) (only measured in craniotomy group)and arterial CO2 partial pressure (PaCO2) will be measured before general anesthesia, at tracheal extubation, and 30,60, 90, 120 min after extubation in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Surgery, Hyperemia
Keywords
Cerebral blood flow, Transcranial Doppler, Emergence from general anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing craniotomy
Arm Type
Experimental
Arm Description
Patients undergoing craniotomy who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited. Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.
Arm Title
Patients undergoing abdominal surgery
Arm Type
Active Comparator
Arm Description
Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler (TCD) measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.
Intervention Type
Device
Intervention Name(s)
Transcranial Doppler (TCD)
Other Intervention Name(s)
TCD
Intervention Description
A 2-MHz Transcranial Doppler probe (MULTI-DOP P2.2C; DWL, Elektronische Systeme GmbH, Germany) will be used to measure both sides of Vmca of both patients undergoing craniotomy and patients undergoing abdominal surgery. The signal will be range-gated to a depth of 45 to 60 mm at temporal bone window to achieve the optimal signal according to standard techniques. The measures will be recorded in the operation room before anesthesia, in the recovery room at extubation, 30, 60, 90, and 120 min after extubation.
Intervention Type
Procedure
Intervention Name(s)
jugular venous bulb catheterization
Other Intervention Name(s)
blood oxygen saturation of jugular vein bulb (SjvO2)
Intervention Description
After local anesthesia, a jugular venous bulb catheter(16G, manufactured by Arrow International Inc. USA) will be placed in the dominant side. The proper placement of the tip of the catheter in the jugular bulb will be confirmed later by a postoperative lateral skull X-ray. SjvO2 (blood sample will be drawn slowly at a speed of 2ml per minute) will be measured before anesthesia, at extubation, 30, 60, 90, and 120 min after extubation.
Intervention Type
Procedure
Intervention Name(s)
Tumor removal surgery under general anesthesia
Other Intervention Name(s)
craniotomy under general anesthesia
Intervention Description
Surgery types include total or subtotal removal of tumors.For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1~2 µg/kg IV), and continuous vecuronium 50~70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.
Intervention Type
Procedure
Intervention Name(s)
Radial artery catheterization
Intervention Description
After local anesthesia, an intra-arterial pressure line(I.V. catheter and pressure line kit are both manufactured by Smiths Medical International Ltd. USA) will be inserted in radial artery. Sample blood will be drawn from the line before anesthesia, at tracheal extubation, and 30, 60, 90, 120 min after tracheal extubation.
Intervention Type
Procedure
Intervention Name(s)
Abdominal surgery under general anesthesia
Intervention Description
For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1~2 µg/kg IV), and continuous vecuronium 50~70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.
Primary Outcome Measure Information:
Title
Mean Blood Flow Velocity in Middle Cerebral Artery
Description
It was the baseline mean blood flow velocity in middle cerebral artery.
Time Frame
before general anesthesia
Title
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame
after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)
Title
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame
30min after extubation
Title
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame
60min after extubation
Title
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame
90min after extubation
Title
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame
120min after extubation
Title
Oxygen Saturation of Jugular Venous Bulb
Time Frame
before general anesthesia
Title
Oxygen Saturation of Jugular Venous Bulb
Time Frame
at extubation
Title
Oxygen Saturation of Jugular Venous Bulb
Time Frame
30min after extubation
Title
Oxygen Saturation of Jugular Venous Bulb
Time Frame
60min after extubation
Title
Oxygen Saturation of Jugular Venous Bulb
Time Frame
90min after extubation
Title
Oxygen Saturation of Jugular Venous Bulb
Time Frame
120min after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesia (ASA) physical status I or II Scheduled for selective supratentorial tumor removal surgery or major abdominal surgery. Exclusion Criteria: Patients with evidence of systemic hypertension, intracranial hypertension, cerebrovascular diseases, other coexisting medical conditions likely to affect cerebral autoregulation. Preoperatively planned delayed tracheal extubation. Pregnant or nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Yu Yang, Master
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shou-Jing Zhou, Master
Organizational Affiliation
Huashan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19952725
Citation
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Results Reference
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PubMed Identifier
16960480
Citation
Randell T, Niskanen M. Management of physiological variables in neuroanaesthesia: maintaining homeostasis during intracranial surgery. Curr Opin Anaesthesiol. 2006 Oct;19(5):492-7. doi: 10.1097/01.aco.0000245273.92163.8e.
Results Reference
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PubMed Identifier
9328850
Citation
Clavier N, Schurando P, Raggueneau JL, Payen DM. Continuous jugular bulb venous oxygen saturation validation and variations during intracranial aneurysm surgery. J Crit Care. 1997 Sep;12(3):112-9. doi: 10.1016/s0883-9441(97)90040-x.
Results Reference
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PubMed Identifier
11867391
Citation
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Results Reference
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PubMed Identifier
18662500
Citation
Rijbroek A, Boellaard R, Vriens EM, Lammertsma AA, Rauwerda JA. Comparison of transcranial Doppler ultrasonography and positron emission tomography using a three-dimensional template of the middle cerebral artery. Neurol Res. 2009 Feb;31(1):52-9. doi: 10.1179/174313208X325191. Epub 2008 Jul 25.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

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