Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01642147

Enrollment

Registered

2012-07-17

Start date

2012-11-30

Completion date

2013-01-31

Last updated

2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms, Surgery, Hyperemia

Keywords

Cerebral blood flow, Transcranial Doppler, Emergence from general anesthesia

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.

Interventions

DEVICETranscranial 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.

PROCEDUREjugular 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.

PROCEDURETumor 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.

PROCEDURERadial 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.

PROCEDUREAbdominal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Blood Flow Velocity in Middle Cerebral Artery	before general anesthesia	It was the baseline mean blood flow velocity in middle cerebral artery.
Oxygen Saturation of Jugular Venous Bulb	before general anesthesia	—

Countries

China

Participant flow

Recruitment details

Recruitment period: 11.01.2012-01.31.2013 Study location: Huashan Hospital Fudan University Location Type: Medical centre affiliated to medical university

Pre-assignment details

Transcranial doppler (TCD) and head CT-scan was used to exclude patients with intracranial hypertension,cerebrovascular diseases, or metastatic brain tumor.

Participants by arm

Arm	Count
Abdominal Surgery Group Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.	30
Craniotomy Group Patients 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.	30
Total	60

Baseline characteristics

Characteristic	Abdominal Surgery Group	Craniotomy Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	30 Participants	30 Participants	60 Participants
Age Continuous	46.6 years STANDARD_DEVIATION 8.2	47.3 years STANDARD_DEVIATION 7.6	47.0 years STANDARD_DEVIATION 7.9
Duration of Surgery	207 minute STANDARD_DEVIATION 49	214 minute STANDARD_DEVIATION 38	211 minute STANDARD_DEVIATION 43
Region of Enrollment China	30 participants	30 participants	60 participants
Sex: Female, Male Female	14 Participants	13 Participants	27 Participants
Sex: Female, Male Male	16 Participants	17 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

Primary