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

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.

Study Overview

• Status: Unknown
• Conditions: Haemodynamic Fluctuations During Off-pump CABG.
• Intervention / Treatment: Drug: Remifentanil; Drug: Sufentanil

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: rob spanjersberg; Email: r.spanjersberg@umcg.nl
    • Principal Investigator: Alain F Kalmar, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remifentanil; Anaesthesia with remifentanil/propofol	Drug: Remifentanil; Anaesthesia with remifentanil/propofol.
Active Comparator: Sufentanil; Anaesthesia with sufentanil/propofol	Drug: Sufentanil; Anaesthesia with sufentanil/propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CO	During anaesthesia

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Alain F Kalmar, MD, PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• Poterman M, Kalmar AF, Buisman PL, Struys MMRF, Scheeren TWL. Improved haemodynamic stability and cerebral tissue oxygenation after induction of anaesthesia with sufentanil compared to remifentanil: a randomised controlled trial. BMC Anesthesiol. 2020 Oct 7;20(1):258. doi: 10.1186/s12871-020-01174-9.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): January 31, 2014
• Last Update Submitted That Met QC Criteria: January 30, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Sufentanil
• Other Study ID Numbers: SuRe-002