Condition category
Circulatory System
Date applied
11/02/2008
Date assigned
27/02/2008
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Young Lan Kwak

ORCID ID

Contact details

Department of Anaesthesiology and Pain Medicine
Anaesthesia and Pain Research Institute
College of Medicine
Yonsei University
134 Shinchon-Dong
Seodaemun-Ku
Seoul
120-752
Korea
South
ylkwak@yuhs.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Near-InfraRed Spectroscopy (NIRS) continuously measures regional cerebral oxygen saturation (rSO2) noninvasively and has been shown to detect even small changes in cerebral oxygen supply-demand balance elicited by etomidate. Propofol and sufentanil have been well studied in human subjects in terms of cerebral oxygen supply-demand balance with both agents decreasing cerebral blood flow and metabolism to a similar degree. Although widely used, only the effect of midazolam on cerebral blood flow has been studied in humans and evidence is lacking about its effect on cerebral metabolic rate. By far, no comprehensive data exist regarding the influence of midazolam and hemodynamic changes on rSO2 scores during the induction period. We therefore evaluated the effect of midazolam on cerebral oxygen supply-demand balance by continuous monitoring of rSO2 in a prospective, randomized and controlled trial with concomitant monitoring of hemodynamic variables including cardiac index and mixed venous oxygen saturation.

Ethics approval

Institutional Review Board (IRB) of Yonsei University Health System, Seoul, Korea. Date of approval: 27 October 2006 (ref: 4-2006-0155)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coronary artery bypass graft surgery

Intervention

Upon arrival at the operating room, standard monitoring devices were applied and a radial artery catheter was inserted under local anaesthesia for continuous blood pressure monitoring. Also, a pulmonary artery catheter (Swan-Ganz CCOmbo, CCO/SvO2, Edwards Lifesciences LLC, USA) was inserted via the right internal jugular vein under local anesthesia for continuous measurement of Cardiac Index (CI) and mixed-venous oxygen saturation (SvO2). Bispectral index (Bispectral Index Scale; BIS) (A-2000TM, Aspect Medical Systems, USA) and rSO2 (INVOS 5100TM, Somanetics, USA) were continuously monitored with both sensors applied to the forehead of the patients.

Hemodynamic variables, BIS and rSO2 scores were recorded at the following time points:
1. Before induction while patients were breathing room air (T1, baseline)
2. After pre-oxygenation with 100% oxygen for at least 3 min through tight-fitting anesthetic mask (T2)
3. Three minutes after administration of either midazolam 0.05 mg/kg or propofol 1 mg/kg according to randomization (T3)
4. Three minutes after completion of administration of sufentanil 1.5–2 µg/kg (T4)
5. Five 5 min after tracheal intubation (T5)

Intervention type

Drug

Phase

Not Specified

Drug names

midazolam and propofol

Primary outcome measures

Regional cerebral oxygen saturation measured by near infrared spectroscopy

Secondary outcome measures

Hemodynamic variables including the following:
1. Cardiac index (CI)
2. Mixed venous oxygen saturation
3. Mean arterial pressure
4. Central venous pressure

Overall trial start date

31/08/2006

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients admitted to the Yonsei University Health System scheduled for isolated off-pump coronary artery bypass graft surgery between August 2006 and March 2007.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients undergoing emergent surgery
2. Pre-existing neurologic disease
3. Lung parenchymal disease
4. New York Heart Association (NYHA) functional class >= 3
5. Left ventricular ejection fraction <40%
6. Unstable angina and recent myocardial infarction within 1 month
7. Patients who had significant luminal narrowing of either carotid and/or vertebral arteries on preoperative angiography

Recruitment start date

31/08/2006

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Anaesthesiology and Pain Medicine
Seoul
120-752
Korea, South

Sponsor information

Organisation

Yonsei University, College of Medicine (Korea, South)

Sponsor details

c/o Dr Jae Kwang Shim
Department of Anaesthesiology and Pain Medicine
Anaesthesia and Pain Research Institute
134 Shinchon-Dong
Seodaemun-Ku
Seoul
120-752
Korea
South
aneshim@yuhs.ac

Sponsor type

University/education

Website

http://medicine.yonsei.ac.kr/en

Funders

Funder type

University/education

Funder name

Yonsei University, College of Medicine (Korea, South)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes