NCT01871935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

May 30, 2013

Last Update Submit

January 30, 2014

Conditions

Haemodynamic Fluctuations During Off-pump CABG.

Outcome Measures

Primary Outcomes (1)

  • CO

    During anaesthesia

Secondary Outcomes (3)

  • MAP

    During anaesthesia

  • Tissue oxygen saturation

    During anaesthesia

  • CO

    During anaesthesia

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Anaesthesia with remifentanil/propofol

Drug: Remifentanil

Sufentanil

ACTIVE COMPARATOR

Anaesthesia with sufentanil/propofol

Drug: Sufentanil

Interventions

RemifentanilDRUG

Anaesthesia with remifentanil/propofol.

Remifentanil
SufentanilDRUG

Anaesthesia with sufentanil/propofol

Sufentanil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33028197DERIVED

MeSH Terms

Interventions

RemifentanilSufentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFentanyl

Study Officials

  • Alain F Kalmar, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain F Kalmar, MD, PhD

CONTACT

a.f.kalmar@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 7, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

June 1, 2014

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

NL(1)