Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil

Not Applicable

• Conditions: Haemodynamic Fluctuations During Off-pump CABG.
• Interventions: Drug: Sufentanil; Drug: Remifentanil

• Registration Number: NCT01871935
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-30
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Primary Completion: 2013-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-01-31
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sufentanil	Sufentanil	Anaesthesia with sufentanil/propofol
Remifentanil	Remifentanil	Anaesthesia with remifentanil/propofol

Primary Outcome Measures

Name	Time	Method
CO	During anaesthesia

Secondary Outcome Measures

Name	Time	Method
Tissue oxygen saturation	During anaesthesia
CO	During anaesthesia	CO obtained by different devices/methods (i.e. the Vigileo device and TEE)
MAP	During anaesthesia

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands