Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiao-Yu Yang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01642147
First received: July 8, 2012
Last updated: May 15, 2013
Last verified: May 2013
  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 (TCD)
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:


Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • Mean Blood Flow Velocity in Middle Cerebral Artery [ Time Frame: before general anesthesia ] [ Designated as safety issue: Yes ]
    It was the baseline mean blood flow velocity in middle cerebral artery.

  • Mean Blood Flow Velocity in Middle Cerebral Artery [ Time Frame: after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min) ] [ Designated as safety issue: Yes ]
  • Mean Blood Flow Velocity in Middle Cerebral Artery [ Time Frame: 30min after extubation ] [ Designated as safety issue: Yes ]
  • Mean Blood Flow Velocity in Middle Cerebral Artery [ Time Frame: 60min after extubation ] [ Designated as safety issue: Yes ]
  • Mean Blood Flow Velocity in Middle Cerebral Artery [ Time Frame: 90min after extubation ] [ Designated as safety issue: Yes ]
  • Mean Blood Flow Velocity in 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 (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.

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.
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: blood oxygen saturation of jugular vein bulb (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 (TCD) measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.
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.
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 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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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: May 15, 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
Hyperemia
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Vascular Diseases
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014