Influence of Cardiopulmonary Bypass, and Sevoflurane or Propofol Anesthesia, on Tissue Oxygen Saturation.

Influence of Cardiopulmonary Bypass and Sevoflurane or Propofol Anesthesia on Tissue Oxygen Saturation of Thenar Muscle in Adults.

The purpose of the present study is to assess, by near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT), the influence of cardiopulmonary bypass on tissue saturation in thenar muscle.

The secondary aim is to compare the effects of propofol and sevoflurane anaesthesia on tissue saturation.

It is a prospective, randomized, open-label study. Sixty cardiac surgery patients will receive either propofol or sevoflurane anaesthesia. Three-minute VOT will be performed at the following time points: 30 minutes after anaesthesia induction, directly after sternotomy, 20 and 40 minutes after aortic cross-clamping, 20 minutes after aortic cross-clamp removal, and 45 minutes after weaning of cardiopulmonary bypass (CPB).

Group and time effects on tissue saturation will be analysed with ANOVA and post hoc Tukey's test.

Study Overview

• Status: Completed
• Conditions: NIR Spectroscopy
• Intervention / Treatment: Procedure: NIRS during VOT; Procedure: General anaesthesia with propofol use; Procedure: General anaesthesia with sevoflurane use

Detailed Description

Near-infrared spectroscopy (NIRS) is a modern technique for cardiac surgical patient monitoring. The NIRS method is based on Lambert-Beer's law, which defines the relationship between the concentration of a substance and reduction of the intensity of electro-magnetic radiation. This reduction results from photon absorption by chromatophores, including haemoglobin, myoglobin and cytochrome P1. Absorption at the given wave-length depends on the degree of chromatophore oxygenation, and hence allows for its assessment. NIRS is currently commonly used for the assessment of brain oximetry in thoracic aorta surgery and, increasingly often, in open-heart surgery. Algorithms for sustaining adequate brain saturation were reported to decrease the incidence of neurological complications following cardiac surgery. In recent years, NIRS was proposed as a tool for the assessment of muscle saturation under short-term ischaemia and reperfusion, referred to as the vascular occlusion test (VOT). VOT is a provocative test in which tissue saturation (StO2) is measured at a peripheral site, such as the thenar eminence, while blood flow is transiently occluded with sphygmomanometer. After reaching a predefined ischaemia time or minimal StO2 threshold, the sphygmomanometer tourniquet is rapidly deflated and blood flow in the muscle is restored. Tissue saturation measurement during VOT can identify early disturbances in tissue metabolism and perfusion. The speed of the decrease in tissue saturation on ischaemia was proposed to reflect the local metabolic rate, while the lowest tissue saturation was proposed to reflect the extent of ischaemia. The speed of tissue saturation recovery on reperfusion in shock patients was proposed as a measure of microvascular capacity to increase blood flow after transient ischaemia. The results of recent studies indicated that the speed of the fall of muscle saturation during VOT is reduced in septic shock, while a decreased speed of saturation recovery on reperfusion is related to disturbed microcirculation, for example in hypovolemic shock. An understanding of anaesthetics and of the influence of cardiac surgical procedures on tissue saturation profile during VOT is essential for the future use of this tool for the assessment of the condition of patients during CPB cardiac surgery.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, PL 80-211
      • Medical University of Gdańsk, Department of Cardiac Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult
• scheduled for elective, open-heart cardiac surgical operation with use of cardiopulmonary bypass.
• signed written consent

Exclusion Criteria:

• surgeon's intention to use the radial artery for arterial bypass
• symptoms of peripheral atherosclerosis
• paresis of a limb
• autoimmune disease
• other factors that could potentially affect blood flow in the upper extremities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; General anaesthesia with Propofol use. Maintenance of anaesthesia in group P will be accomplished using continuous intravenous infusion of propofol 2-4 mg kg/h. Propofol infusion rate will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with Bispectral Index (BIS), with a target range of 40-60. Intervention: NIRS during VOT on several timepoints.	Procedure: NIRS during VOT; Near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT) on following timepoints: 30 minutes after anaesthesia induction,; directly after the sternotomy,; during CPB - 20 minutes after aortic cross-clamping ,; 40 minutes after aortic cross-clamping,; 20 minutes after the release of the aortic cross-clamp,; 45 minutes after weaning of CPB.; Procedure: General anaesthesia with propofol use; Premedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre. Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure. Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg. Maintenance of anaesthesia in 'Propofol' group will be accomplished using continuous intravenous infusion of propofol 2-4 mg kg/h. Propofol infusion rate will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with Bispectral Index (BIS), with a target range of 40-60.; Other Names: Propofol Total Intravenous Anesthesia (TIVA)
Experimental: Sevoflurane; General anaesthesia with sevoflurane use. Sevoflurane concentration in exhaled gas will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with BIS, with a target range of 40-60. Intervention: NIRS during VOT on several timepoints.	Procedure: NIRS during VOT; Near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT) on following timepoints: 30 minutes after anaesthesia induction,; directly after the sternotomy,; during CPB - 20 minutes after aortic cross-clamping ,; 40 minutes after aortic cross-clamping,; 20 minutes after the release of the aortic cross-clamp,; 45 minutes after weaning of CPB.; Procedure: General anaesthesia with sevoflurane use; Premedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre. Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure. Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg. Sevoflurane concentration in exhaled gas will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with BIS, with a target range of 40-60.; Other Names: Sevoflurane anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in thenar muscle saturation	Thenar muscle tissue saturation was continuously monitored using an INVOS NIRS monitor (INVOS-YM 5100C Cerebral Somatic Oximeter, Covidien, Mansfield, USA). Thenar muscle saturation was measured during VOT 30 minutes after anaesthesia induction, which will be regarded baseline value. At five another timepoints VOT was performed and changes in thenar muscle saturation were measured: directly after the sternotomy,; during CPB - 20 minutes after aortic cross-clamping,; 40 minutes after aortic cross-clamping,; 20 minutes after the release of the aortic cross-clamp,; 45 minutes after weaning of CPB.	During VOT performed at 6 timepoints

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Alexandra Biedrzycka, M.D., Ph.D., Medical University of Gdańsk, Department of Cardiac Anesthesiology

Publications and helpful links

General Publications

• Biedrzycka A, Kowalik M, Pawlaczyk R, Jagielak D, Swietlik D, Szymanowicz W, Lango R. Aortic cross-clamping phase of cardiopulmonary bypass is related to decreased microvascular reactivity after short-term ischaemia of the thenar muscle both under intravenous and volatile anaesthesia: a randomized trial. Interact Cardiovasc Thorac Surg. 2016 Nov;23(5):770-778. doi: 10.1093/icvts/ivw232. Epub 2016 Jul 8.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Cardiopulmonary Bypass; Anoxia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Sevoflurane
• Other Study ID Numbers: NKBN/34/2012