Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

NCT01642147 | Completed Results DMC

• 1 other identifier: KY2012-183
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Neoplasms; Surgery; Hyperemia

Keywords

Cerebral blood flow; Transcranial Doppler; Emergence from general anesthesia

Outcome Measures

Primary Outcomes (12)

• Mean Blood Flow Velocity in Middle Cerebral Artery

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

  before general anesthesia

• Mean Blood Flow Velocity in Middle Cerebral Artery

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

• Mean Blood Flow Velocity in Middle Cerebral Artery

  30min after extubation

• Mean Blood Flow Velocity in Middle Cerebral Artery

  60min after extubation

• Mean Blood Flow Velocity in Middle Cerebral Artery

  90min after extubation

• Mean Blood Flow Velocity in Middle Cerebral Artery

  120min after extubation

• Oxygen Saturation of Jugular Venous Bulb

  before general anesthesia

• Oxygen Saturation of Jugular Venous Bulb

  at extubation

• Oxygen Saturation of Jugular Venous Bulb

  30min after extubation

• Oxygen Saturation of Jugular Venous Bulb

  60min after extubation

• Oxygen Saturation of Jugular Venous Bulb

  90min after extubation

• Oxygen Saturation of Jugular Venous Bulb

  120min after extubation

Study Arms (2)

Patients undergoing craniotomy

EXPERIMENTAL

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); Procedure: jugular venous bulb catheterization; Procedure: Tumor removal surgery under general anesthesia; Procedure: Radial artery catheterization

Patients undergoing abdominal surgery

ACTIVE COMPARATOR

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); Procedure: Radial artery catheterization; Procedure: Abdominal surgery under general anesthesia

Interventions

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.

Also known as: TCD

Patients undergoing abdominal surgery; Patients undergoing craniotomy

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.

Also known as: blood oxygen saturation of jugular vein bulb (SjvO2)

Patients undergoing craniotomy

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.

Also known as: craniotomy under general anesthesia

Patients undergoing craniotomy

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.

Patients undergoing abdominal surgery; Patients undergoing craniotomy

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.

Patients undergoing abdominal surgery

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesia (ASA) physical status I or II
• Scheduled for selective supratentorial tumor removal surgery or major abdominal surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (7)

• Rasmussen M, Juul N, Christensen SM, Jonsdottir KY, Gyldensted C, Vestergaard-Poulsen P, Cold GE, Ostergaard 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.

  PMID: 19952725 BACKGROUND

• Randell T, Niskanen M. Management of physiological variables in neuroanaesthesia: maintaining homeostasis during intracranial surgery. Curr Opin Anaesthesiol. 2006 Oct;19(5):492-7. doi: 10.1097/01.aco.0000245273.92163.8e.

  PMID: 16960480 BACKGROUND

• 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. doi: 10.1016/s0883-9441(97)90040-x.

  PMID: 9328850 BACKGROUND

• 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. doi: 10.1097/00000539-200203000-00031.

  PMID: 11867391 BACKGROUND

• 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.

  PMID: 18662500 BACKGROUND

• 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. doi: 10.7863/jum.2010.29.7.1017.

  PMID: 20587424 BACKGROUND

• Macmillan CS, Andrews PJ. Cerebrovenous oxygen saturation monitoring: practical considerations and clinical relevance. Intensive Care Med. 2000 Aug;26(8):1028-36. doi: 10.1007/s001340051315.

  PMID: 11030158 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Hyperemia

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Limitations and Caveats

The study population was not homogenous according to tumor size and location.

Results Point of Contact

• Title: Xiao-Yu Yang
• Organization: Huashan Hospital Fudan University

xiaoyuyangfudan@gmail.com

086-021-52889999

Study Officials

• Xiao-Yu Yang, Master

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Shou-Jing Zhou, Master

  Huashan Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2012
• First Posted: July 17, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 24, 2013
• Results First Posted: April 23, 2013

Record last verified: 2013-05

Locations

CN (1)