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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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 |
| Countries of recruitment | Korea, South |
| Disease/condition/study domain | Coronary artery bypass graft surgery |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 31/08/2006 |
| Anticipated end date | 31/03/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 60 |
| Interventions |
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) |
| Primary outcome measure(s) | Regional cerebral oxygen saturation measured by near infrared spectroscopy |
| Secondary outcome measure(s) |
Hemodynamic variables including the following:
1. Cardiac index (CI) 2. Mixed venous oxygen saturation 3. Mean arterial pressure 4. Central venous pressure |
| Sources of funding |
Yonsei University, College of Medicine (Korea, South)
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| Trial website | |
| Publications | |
| Contact name | Dr Young Lan Kwak |
| Address |
Department of Anaesthesiology and Pain Medicine
Anaesthesia and Pain Research Institute College of Medicine Yonsei University 134 Shinchon-Dong Seodaemun-Ku |
| City/town | Seoul |
| Zip/Postcode | 120-752 |
| Country | Korea, South |
| ylkwak@yuhs.ac | |
| Sponsor | Yonsei University, College of Medicine (Korea, South) |
| Address |
c/o Dr Jae Kwang Shim
Department of Anaesthesiology and Pain Medicine Anaesthesia and Pain Research Institute 134 Shinchon-Dong Seodaemun-Ku |
| City/town | Seoul |
| Zip/Postcode | 120-752 |
| Country | Korea, South |
| aneshim@yuhs.ac | |
| Sponsor website: | http://medicine.yonsei.ac.kr/en |
| Date applied | 11/02/2008 |
| Last edited | 27/02/2008 |
| Date ISRCTN assigned | 27/02/2008 |
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