Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

May 15, 2013 updated by: Xiao-Yu Yang, Huashan Hospital

Cerebral Hyperemia During Emergence From General Anesthesia for Craniotomy of Patients With Brain Tumor

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing craniotomy

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.
Device: Transcranial Doppler (TCD)
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.
Other Names:
  • TCD
Procedure: jugular venous bulb catheterization
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.
Other Names:
  • blood oxygen saturation of jugular vein bulb (SjvO2)
Procedure: Tumor removal surgery under general anesthesia
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.
Other Names:
  • craniotomy under general anesthesia
Procedure: Radial artery catheterization
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.
Active Comparator: Patients undergoing abdominal surgery
Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler (TCD) measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.
Device: Transcranial Doppler (TCD)
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.
Other Names:
  • TCD
Procedure: Radial artery catheterization
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.
Procedure: Abdominal surgery under general anesthesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame: before general anesthesia
It was the baseline mean blood flow velocity in middle cerebral artery.
before general anesthesia
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame: after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)
after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame: 30min after extubation
30min after extubation
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame: 60min after extubation
60min after extubation
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame: 90min after extubation
90min after extubation
Mean Blood Flow Velocity in Middle Cerebral Artery
Time Frame: 120min after extubation
120min after extubation
Oxygen Saturation of Jugular Venous Bulb
Time Frame: before general anesthesia
before general anesthesia
Oxygen Saturation of Jugular Venous Bulb
Time Frame: at extubation
at extubation
Oxygen Saturation of Jugular Venous Bulb
Time Frame: 30min after extubation
30min after extubation
Oxygen Saturation of Jugular Venous Bulb
Time Frame: 60min after extubation
60min after extubation
Oxygen Saturation of Jugular Venous Bulb
Time Frame: 90min after extubation
90min after extubation
Oxygen Saturation of Jugular Venous Bulb
Time Frame: 120min after extubation
120min after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Xiao-Yu Yang, Master, Huashan Hospital
  • Study Chair: Shou-Jing Zhou, Master, Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 8, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2012-183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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