Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642147
• Other study ID #: KY2012-183
• Status: Completed
• Phase: N/A
• First received: July 8, 2012
• Last updated: May 15, 2013
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai MunicipalityChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Neoplasms
• Hyperemia
• Surgery

Intervention

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.

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Bruder N, Pellissier D, Grillot P, Gouin F. Cerebral hyperemia during recovery from general anesthesia in neurosurgical patients. Anesth Analg. 2002 Mar;94(3):650-4; table of contents. — View 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. — View Citation

Macmillan CS, Andrews PJ. Cerebrovenous oxygen saturation monitoring: practical considerations and clinical relevance. Intensive Care Med. 2000 Aug;26(8):1028-36. Review. — View 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. Review. — View Citation

Rasmussen M, Juul N, Christensen SM, Jónsdóttir KY, Gyldensted C, Vestergaard-Poulsen P, Cold GE, Østergaard L. Cerebral blood flow, blood volume, and mean transit time responses to propofol and indomethacin in peritumor and contralateral brain regions: perioperative perfusion-weighted magnetic resonance imaging in patients with brain tumors. Anesthesiology. 2010 Jan;112(1):50-6. doi: 10.1097/ALN.0b013e3181c38bd3. — View 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. — View Citation

Sorond FA, Hollenberg NK, Panych LP, Fisher ND. Brain blood flow and velocity: correlations between magnetic resonance imaging and transcranial Doppler sonography. J Ultrasound Med. 2010 Jul;29(7):1017-22. — View Citation

Outcome

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