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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huashan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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