Assessment of cerebral oxygen supply-demand balance by near-infrared spectroscopy during induction of anesthesia in patients undergoing coronary artery bypass graft surgery: Comparison of midazolam with propofol

ISRCTN	ISRCTN52666802
DOI	https://doi.org/10.1186/ISRCTN52666802
Secondary identifying numbers	N/A

Submission date: 11/02/2008
Registration date: 27/02/2008
Last edited: 16/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Young Lan Kwak
Scientific

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

Email	ylkwak@yuhs.ac

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
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(s)	Institutional Review Board (IRB) of Yonsei University Health System, Seoul, Korea. Date of approval: 27 October 2006 (ref: 4-2006-0155)
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 1.52 µg/kg (T4) 5. Five 5 min after tracheal intubation (T5)
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	midazolam and propofol
Primary outcome measure	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 study start date	31/08/2006
Overall study end date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
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 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

Study participating centre

Department of Anaesthesiology and Pain Medicine

Seoul
120-752
Korea, South

Sponsor information

Yonsei University, College of Medicine (Korea, South)
University/education

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

Email	aneshim@yuhs.ac
Website	http://medicine.yonsei.ac.kr/en
"ROR"	https://ror.org/01wjejq96

Funders

Funder type

University/education

Yonsei University, College of Medicine (Korea, South)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan