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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: Trade Name: sufentanil Product Name: Sufentanil Citrate USP Product Code: 60561‐17‐3 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: SUFENTANIL CAS Number: 56030‐54‐7 Concentration unit: µg/kg microgram(s)/kilogram Concentration type: range Concentration number: 0.5‐5.0 Trade Name: remifentanil Product Name: ultiva Product Code: 437‐38‐7 Pharmaceutical Form: Concentrate for dip solution INN or Proposed INN: REMIFENTANIL CAS Number: 132875‐61‐7 Concentration unit: µg/kg microgram(s)/kilogram Concentration type: range Concentration number: 0.5‐5.0 CONDITION: 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] PRIMARY OUTCOME: 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 Primary end point(s): The change in CO (continuous measurement of the Nexfin monitor) around the moment of atropine administration. Secondary Objective: The evolution of MAP, SctO2 and SptO2 around the moment of atropine administration? Timepoint(s) of evaluation of this end point: end of the operation SECONDARY OUTCOME: 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 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
Epistemonikos ID: 88bfd1495c5bac1677ba7bb8a7ab12a1444cc7e0
First added on: Aug 22, 2024