Clinical trial NCT01642147: Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy
Official title: Cerebral Hyperemia During Emergence From General Anesthesia for Craniotomy of Patients With Brain Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasms
Surgery
Hyperemia
Keywords: Cerebral blood flow
Transcranial Doppler
Emergence from general anesthesia
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Mean Blood Flow Velocity in Middle Cerebral Artery
timeFrame: before general anesthesia
measure: Mean Blood Flow Velocity in Middle Cerebral Artery
timeFrame: after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)
measure: Mean Blood Flow Velocity in Middle Cerebral Artery
timeFrame: 30min after extubation
measure: Mean Blood Flow Velocity in Middle Cerebral Artery
timeFrame: 60min after extubation
measure: Mean Blood Flow Velocity in Middle Cerebral Artery
timeFrame: 90min after extubation
measure: Mean Blood Flow Velocity in Middle Cerebral Artery
timeFrame: 120min after extubation
measure: Oxygen Saturation of Jugular Venous Bulb
timeFrame: before general anesthesia
measure: Oxygen Saturation of Jugular Venous Bulb
timeFrame: at extubation
measure: Oxygen Saturation of Jugular Venous Bulb
timeFrame: 30min after extubation
measure: Oxygen Saturation of Jugular Venous Bulb
timeFrame: 60min after extubation
measure: Oxygen Saturation of Jugular Venous Bulb
timeFrame: 90min after extubation
measure: Oxygen Saturation of Jugular Venous Bulb
timeFrame: 120min after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Xiao-Yu Yang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Shou-Jing Zhou, Master
role: STUDY_CHAIR
References:
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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. doi: 10.7863/jum.2010.29.7.1017.
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