Trial Outcomes & Findings for Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy (NCT NCT01642147)

NCT ID: NCT01642147

Last Updated: 2013-06-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

before general anesthesia

Results posted on

2013-06-24

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abdominal Surgery Group n=30 Participants Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.	Craniotomy Group n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	46.6 years STANDARD_DEVIATION 8.2 • n=5 Participants	47.3 years STANDARD_DEVIATION 7.6 • n=7 Participants	47.0 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment China	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Duration of Surgery	207 minute STANDARD_DEVIATION 49 • n=5 Participants	214 minute STANDARD_DEVIATION 38 • n=7 Participants	211 minute STANDARD_DEVIATION 43 • n=5 Participants

PRIMARY outcome

Timeframe: before general anesthesia

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

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

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	Abdominal Surgery Group n=30 Participants Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
Mean Blood Flow Velocity in Middle Cerebral Artery	63.7 cm/s Standard Deviation 6.7	61.8 cm/s Standard Deviation 8.1

PRIMARY outcome

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

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	Abdominal Surgery Group n=30 Participants Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
Mean Blood Flow Velocity in Middle Cerebral Artery	95.7 cm/s Standard Deviation 16.9	63.6 cm/s Standard Deviation 7.7

PRIMARY outcome

Timeframe: 30min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	Abdominal Surgery Group n=30 Participants Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
Mean Blood Flow Velocity in Middle Cerebral Artery	82.5 cm/s Standard Deviation 12.0	62.0 cm/s Standard Deviation 8.0

PRIMARY outcome

Timeframe: 60min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	Abdominal Surgery Group n=30 Participants Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
Mean Blood Flow Velocity in Middle Cerebral Artery	77.0 cm/s Standard Deviation 12.1	61.2 cm/s Standard Deviation 7.9

PRIMARY outcome

Timeframe: 90min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	Abdominal Surgery Group n=30 Participants Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
Mean Blood Flow Velocity in Middle Cerebral Artery	72.8 cm/s Standard Deviation 11.0	60.1 cm/s Standard Deviation 8.0

PRIMARY outcome

Timeframe: 120min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	Abdominal Surgery Group n=30 Participants Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
Mean Blood Flow Velocity in Middle Cerebral Artery	69.7 cm/s Standard Deviation 9.0	59.2 cm/s Standard Deviation 7.8

PRIMARY outcome

Timeframe: before general anesthesia

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	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.
Oxygen Saturation of Jugular Venous Bulb	60.9 percentage of oxygen saturation Standard Deviation 3.7	—

PRIMARY outcome

Timeframe: at extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	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.
Oxygen Saturation of Jugular Venous Bulb	81.4 percentage of oxygen saturation Standard Deviation 7.4	—

PRIMARY outcome

Timeframe: 30min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	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.
Oxygen Saturation of Jugular Venous Bulb	77.0 percentage of oxygen saturation Standard Deviation 6.4	—

PRIMARY outcome

Timeframe: 60min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	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.
Oxygen Saturation of Jugular Venous Bulb	71.8 percentage of oxygen saturation Standard Deviation 6.5	—

PRIMARY outcome

Timeframe: 90min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	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.
Oxygen Saturation of Jugular Venous Bulb	68.8 percentage of oxygen saturation Standard Deviation 6.4	—

PRIMARY outcome

Timeframe: 120min after extubation

Population: The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Outcome measures

Outcome measures
Measure	Craniotomy Group n=30 Participants 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.	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.
Oxygen Saturation of Jugular Venous Bulb	66.9 percentage of oxygen saturation Standard Deviation 5.9	—

Adverse Events

Abdominal Surgery Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Craniotomy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Xiao-Yu Yang

Huashan Hospital Fudan University

Phone: 086-021-52889999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place