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Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil

Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01871935
Enrollment
70
Registered
2013-06-07
Start date
2013-06-30
Completion date
2014-06-30
Last updated
2014-01-31

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

Conditions

Haemodynamic Fluctuations During Off-pump CABG.

Brief summary

Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil. Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.

Interventions

DRUGRemifentanil

Anaesthesia with remifentanil/propofol.

DRUGSufentanil

Anaesthesia with sufentanil/propofol

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age: 18 years and older. * Elective CABG surgery performed off-pump. * Written informed consent to participate in this study. * Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

Exclusion criteria

* 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

MeasureTime frame
CODuring anaesthesia

Secondary

MeasureTime frameDescription
MAPDuring anaesthesia
Tissue oxygen saturationDuring anaesthesia
CODuring anaesthesiaCO obtained by different devices/methods (i.e. the Vigileo device and TEE)

Countries

Netherlands

Contacts

Primary ContactAlain F Kalmar, MD, PhD
a.f.kalmar@umcg.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026