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

NCT02593448 | Completed Phase 4

• 1 other identifier: NKBN/34/2012
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NIR Spectroscopy

Keywords

Cardiopulmonary Bypass; Anoxia

Outcome Measures

Primary Outcomes (1)

• 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: 1. directly after the sternotomy, 2. during CPB - 20 minutes after aortic cross-clamping, 3. 40 minutes after aortic cross-clamping, 4. 20 minutes after the release of the aortic cross-clamp, 5. 45 minutes after weaning of CPB.

  During VOT performed at 6 timepoints

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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; Procedure: General anaesthesia with propofol use

Sevoflurane

EXPERIMENTAL

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; Procedure: General anaesthesia with sevoflurane use

Interventions

NIRS during VOT PROCEDURE

Near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT) on following timepoints: 1. 30 minutes after anaesthesia induction, 2. directly after the sternotomy, 3. during CPB - 20 minutes after aortic cross-clamping , 4. 40 minutes after aortic cross-clamping, 5. 20 minutes after the release of the aortic cross-clamp, 6. 45 minutes after weaning of CPB.

Propofol; Sevoflurane

General anaesthesia with propofol use PROCEDURE

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.

Also known as: Propofol Total Intravenous Anesthesia (TIVA)

Propofol

General anaesthesia with sevoflurane use PROCEDURE

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.

Also known as: Sevoflurane anaesthesia

Sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk, Department of Cardiac Anesthesiology

Gdansk, Pomeranian Voivodeship, PL 80-211, Poland

Location

Related Publications (1)

• 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.

  PMID: 27401083 DERIVED

MeSH Terms

Conditions

Hypoxia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Alexandra Biedrzycka, M.D., Ph.D.

  Medical University of Gdańsk, Department of Cardiac Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr hab. med. Romuald Lango

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: November 2, 2015
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2014
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

PL (1)