Evaluation of the effect of 80% versus 30% supplemental oxygen administration during major abdominal surgery on postoperative brain natriuretic peptide concentration. MedDRA version: 20.0 Level: PT Classification code 10059883 Term: Fraction of inspired oxygen System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10050322 Term: Oxygen supplementation System Organ Class: 100000173317
Conditions
Interventions
Product Name: Oxygen
Pharmaceutical Form: Medicinal gas, liquefied
INN or Proposed INN: OXYGEN
CAS Number: 7782-44-7
Current Sponsor code: Oxygen
Other descriptive name: molecular oxygen, oxygen molec
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non-cardiac surgery: 1. History of coronary artery disease 2. History of peripheral arterial disease 3. History of stroke OR 4. Any of 3 of 7 A) Age = 70 years B) Undergoing major surgery C) History of congestive heart failure D) History of transient ischemic attack E) Diabetes and currently taking an oral hypoglycemic agent or insulin F) History of Hypertension Further inclusion criteria are: 1. Written informed consent 2. Elective major abdominal open surgery or laparoscopically assisted procedures scheduled to take over two hours done under general anesthesia (colorectal, urology, gynecology, liver and pancreatic surgery) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Symptoms of infection or sepsis 2. Preoperative inotropic therapy 3. Patients under ICU treatment 4. Oxygen dependent patients 5. History of severe heart failure and/or EF < 30%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Due to the significant reduction of BNP by inhibiting sympathic nerve activity we hypothesize that supplemental oxygen have beneficial effects in perioperative BNP release in cardiac risk patients undergoing major abdominal surgery. ;Secondary Objective: 1) Effect of supplemental oxygen on postoperative troponin T concentration. 2) Influence of supplemental oxygen on perioperative plasma catecholamine concentration. 3) The effect of oxygen on the redox potential. 4) The effect of hyperoxia on needed vasopressor for hemodynamic stability due to enhanced vasoconstriction 5) Endothelial release of vWF in order to evaluate the endothelial response to supplemental oxygen. ;Primary end point(s): Supplemental oxygen leads to a significant reduction of BNP in patients suffering congestive heart failure due to inhibiting of sympathic nerve activity. In the following trial, we want to evaluate the effect of supplemental intraoperative oxygen in cardiac risk patients undergoing major surgery. Our primary outcome parameter will be the perioperative brain natriuretic peptide.;Timepoint(s) of evaluation of this end point: Brain natriuretic peptide measurement will be performed within 2 hours after end of surgery, on postoperative day 1, 3 and before discharge but at least within 72hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Harmful effects of hyperoxia were described in patients suffering acute myocardial syndrome, however almost no data exists about patients in the perioperative setting without an acute myocardial event. Myocardial injury after noncardiac surgery (MINS) is associated with significant increased 30-day mortality. Patients with a troponin T level > 0.04ng/l will be assessed for ischemic features. 2) All participants will be monitored for cardiac morbidity as there are: a) myocardial infarction requiring medical intervention, b) acute heart failure requiring medical therapy (diuretics, positive inotropes therapy, invasive and non-invavisve respiratory support) c) new onset of cardiac arrhythmias needing intervention d) unplanned ICU admission due to cardiac events. 3) Patients experience a significant raise in plasma catecholamines during surgery. Because of the association between intraoperative raise of catecholamines and postoperative cardiovascular risk we will also measure perioperative catecholamine (e.g. adrenaline, noradrenaline, dopamine) concentration. Supplemental oxygen leads to a decrease of sympathetic nerve activity followed by lower plasma catecholamine concentrations. Therefore, we perform a baseline measurement immediately after induction of anesthesia, one after surgery and one on third postoperative day. 4) The antioxidant capacity of a plasma sample, will be measured based on the electrical conductance relative to an internal reference standard. The plasma sample will be obtained preoperatively, hourly and immediately after end of surgery and on postoperative day 1 and 3 and before discharge but at least within 72hours. 5) Supplemental oxygen might have a vasopressor sparing effect. Consequently, the number of administered boluses as well as the total dose of phenylephrine and norepinephrine will be recorded. 6) The immune modulator effect of supplemental oxygen remains still unknown. Because of an enhanced endothelia | — |
Countries
Austria
Contacts
Public ContactHead Office
Department for Anaesthesia, Office Care and Pain Management
Outcome results
None listed