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NCT Number: NCT01642147

Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Hyperemia Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Surgery Vascular Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler (TCD)

Device

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

jugular venous bulb catheterization

Procedure

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)

Tumor removal surgery under general anesthesia

Procedure

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

Radial artery catheterization

Procedure

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.

Abdominal surgery under general anesthesia

Procedure

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 outcomes

  1. 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.

  2. Mean Blood Flow Velocity in Middle Cerebral Artery

    Time frame: after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)

  3. Mean Blood Flow Velocity in Middle Cerebral Artery

    Time frame: 30min after extubation

  4. Mean Blood Flow Velocity in Middle Cerebral Artery

    Time frame: 60min after extubation

  5. Mean Blood Flow Velocity in Middle Cerebral Artery

    Time frame: 90min after extubation

  6. Mean Blood Flow Velocity in Middle Cerebral Artery

    Time frame: 120min after extubation

  7. Oxygen Saturation of Jugular Venous Bulb

    Time frame: before general anesthesia

  8. Oxygen Saturation of Jugular Venous Bulb

    Time frame: at extubation

  9. Oxygen Saturation of Jugular Venous Bulb

    Time frame: 30min after extubation

  10. Oxygen Saturation of Jugular Venous Bulb

    Time frame: 60min after extubation

  11. Oxygen Saturation of Jugular Venous Bulb

    Time frame: 90min after extubation

  12. Oxygen Saturation of Jugular Venous Bulb

    Time frame: 120min after extubation

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2012
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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