Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 25 to 60 years
• All sexes
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Brain Neoplasms, Surgery, Hyperemia

Being tested

Transcranial Doppler (TCD), jugular venous bulb catheterization, Tumor removal surgery under general anesthesia, Radial artery catheterization, Abdominal surgery under general anesthesia

Keywords

Cerebral blood flow, Transcranial Doppler, Emergence from general anesthesia

Medical subject headings

Brain Neoplasms, Hyperemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Transcranial Doppler (TCD)Device

  Also called 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.

• jugular venous bulb catheterizationProcedure or surgery

  Also called blood oxygen saturation of jugular vein bulb (SjvO2)

  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.

• Tumor removal surgery under general anesthesiaProcedure or surgery

  Also called craniotomy 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.

• Radial artery catheterizationProcedure or surgery

  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 anesthesiaProcedure or surgery

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. Mean Blood Flow Velocity in Middle Cerebral Artery

   It was the baseline mean blood flow velocity in middle cerebral artery.

   Measured: before general anesthesia

2. Mean Blood Flow Velocity in Middle Cerebral Artery

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

3. Mean Blood Flow Velocity in Middle Cerebral Artery

   Measured: 30min after extubation

4. Mean Blood Flow Velocity in Middle Cerebral Artery

   Measured: 60min after extubation

5. Mean Blood Flow Velocity in Middle Cerebral Artery

   Measured: 90min after extubation

6. Mean Blood Flow Velocity in Middle Cerebral Artery

   Measured: 120min after extubation

7. Oxygen Saturation of Jugular Venous Bulb

   Measured: before general anesthesia

8. Oxygen Saturation of Jugular Venous Bulb

   Measured: at extubation

9. Oxygen Saturation of Jugular Venous Bulb

   Measured: 30min after extubation

10. Oxygen Saturation of Jugular Venous Bulb

    Measured: 60min after extubation

11. Oxygen Saturation of Jugular Venous Bulb

    Measured: 90min after extubation

12. Oxygen Saturation of Jugular Venous Bulb

    Measured: 120min after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Jul 2012 (estimated)
2. Study startNov 2012
3. Primary completionJan 2013
4. Study completionJan 2013

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (7)Papers the sponsor has linked to this study.
• Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.