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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002533-10-NL

Enrollment

Registered

2012-07-03

Start date

2013-05-22

Completion date

Unknown

Last updated

2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Contacts

Public Contacta.kalmar

umcg

a.kalmar@umcg.nl00310503616161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026