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Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil

NCT ID: NCT01871935

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Haemodynamic Fluctuations During Off-pump CABG.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Remifentanil

Anaesthesia with remifentanil/propofol

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Anaesthesia with remifentanil/propofol.

Sufentanil

Anaesthesia with sufentanil/propofol

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Anaesthesia with sufentanil/propofol

Interventions

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Remifentanil

Anaesthesia with remifentanil/propofol.

Intervention Type DRUG

Sufentanil

Anaesthesia with sufentanil/propofol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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A.F.Kalmar

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alain F Kalmar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Alain F Kalmar, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Rob Spanjersberg

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33028197 (View on PubMed)

Other Identifiers

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SuRe-002

Identifier Type: -

Identifier Source: org_study_id