Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy - Full Text View

Purpose

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.

Condition	Intervention
Brain Neoplasms Surgery Hyperemia	Device: Transcranial Doppler Procedure: jugular venous bulb catheterization Procedure: Tumor removal surgery under general anesthesia Procedure: Radial artery catheterization Procedure: Abdominal surgery under general anesthesia

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Cerebral Hyperemia During Emergence From General Anesthesia for Craniotomy of Patients With Brain Tumor

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Huashan Hospital:

Primary Outcome Measures:

Mean Velocity of Middle Cerebral Artery [ Time Frame: before general anesthesia ] [ Designated as safety issue: Yes ]
It was the baseline mean velocity of middle cerebral artery.
Mean Velocity of Middle Cerebral Artery [ Time Frame: after surgery at extubation ] [ Designated as safety issue: Yes ]
Mean Velocity of Middle Cerebral Artery 30min After Extubation [ Time Frame: 30min after extubation ] [ Designated as safety issue: Yes ]
Mean Velocity of Middle Cerebral Artery [ Time Frame: 60min after extubation ] [ Designated as safety issue: Yes ]
Mean Velocity of Middle Cerebral Artery [ Time Frame: 90min after extubation ] [ Designated as safety issue: Yes ]
Mean Velocity of Middle Cerebral Artery [ Time Frame: 120min after extubation ] [ Designated as safety issue: Yes ]
Oxygen Saturation of Jugular Venous Bulb [ Time Frame: before general anesthesia ] [ Designated as safety issue: Yes ]
Oxygen Saturation of Jugular Venous Bulb [ Time Frame: at extubation ] [ Designated as safety issue: Yes ]
Oxygen Saturation of Jugular Venous Bulb [ Time Frame: 30min after extubation ] [ Designated as safety issue: Yes ]
Oxygen Saturation of Jugular Venous Bulb [ Time Frame: 60min after extubation ] [ Designated as safety issue: Yes ]
Oxygen Saturation of Jugular Venous Bulb [ Time Frame: 90min after extubation ] [ Designated as safety issue: Yes ]
Oxygen Saturation of Jugular Venous Bulb [ Time Frame: 120min after extubation ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	November 2012
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patients undergoing craniotomy Patients undergoing craniotomy who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited. Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.	Device: Transcranial Doppler 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 Name: 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 Name: jugular venous oxygen saturation (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 Name: 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 measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.	Device: Transcranial Doppler 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 Name: 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.

Arms

Assigned Interventions

Experimental: Patients undergoing craniotomy

Patients undergoing craniotomy who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.

Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.

Device: Transcranial Doppler

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 Name: 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 Name: jugular venous oxygen saturation (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 Name: 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 measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.

Device: Transcranial Doppler

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 Name: 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.

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 velocity of middle cerebral artery (Vmca), mean arterial pressure (MAP), 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.

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA(American Society of Anesthesia) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642147

Locations

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

Sponsors and Collaborators

Huashan Hospital

Investigators

Principal Investigator:	Xiao-Yu Yang, Master	Fudan University
Study Chair:	Shou-Jing Zhou, Master	Fudan University

More Information

Publications:

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.

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.

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.

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.

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. Epub 2008 Jul 25.

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.

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

Responsible Party:	Xiao-Yu Yang, Principal Investigator, Huashan Hospital
ClinicalTrials.gov Identifier:	NCT01642147 History of Changes
Other Study ID Numbers:	KY2012-183
Study First Received:	July 8, 2012
Results First Received:	March 9, 2013
Last Updated:	March 9, 2013
Health Authority:	China: Science and Technology Commission of Shanghai Municipality China: Ethics Committee

Keywords provided by Huashan Hospital:

Cerebral blood flow
Transcranial Doppler
Emergence from general anesthesia

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Hyperemia
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013