Comparison of the effects of atropine on haemodynamics and tissue oxygenation in anaesthesia with propofol and sufentanil versus propofol and remifentanil’

Conditions: Comparison of the effects of atropine on haemodynamics and tissue oxygenation in anaesthesia with propofol and sufentanil versus propofol and remifentanil
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-002533-10-NL

Lead Sponsor: MCG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 70

Inclusion Criteria

All adult patients scheduled for elective off-pump CABG surgery in which sufentanil and remifentanil are equally preferable analgesics. No selection will be made regarding gender, age, ASA-classification, co-morbidity or ethnic background.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Refusal to participate in this study.
-Age: younger than 18 years.
-Pregnant.
-BMI > 35 kg/m2.
-Patients in which atropine is contra-indicated.
-Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
-Urgent or emergency surgery.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if there is a clinically important different effect of atropine on haemodynamic variables, tissue oxygenation or microcirculation during anaesthesia with either sufentanil and propofol or with remifentanil and propofol;Secondary Objective: The evolution of MAP, SctO2 and SptO2 around the moment of atropine administration?;Primary end point(s): The change in CO (continuous measurement of the Nexfin monitor) around the moment of atropine administration. ;Timepoint(s) of evaluation of this end point: end of the operation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The evolution of MAP, SctO2 and SptO2 around the moment of atropine administration;Timepoint(s) of evaluation of this end point: end of operation