Haemodynamic Fluctuations During Off-pump CABG. Clinical Trial
Official title:
Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil
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.
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | June 2014 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | University Medical Center Groningen | Groningen |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Center Groningen |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CO | During anaesthesia | No | |
| Secondary | MAP | During anaesthesia | No | |
| Secondary | Tissue oxygen saturation | During anaesthesia | No | |
| Secondary | CO | CO obtained by different devices/methods (i.e. the Vigileo device and TEE) | During anaesthesia | No |