NCT03517735

Brief Summary

This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

April 19, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

April 19, 2018

Last Update Submit

October 28, 2021

Conditions

AnesthesiaSedationSurgery, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Adequate sedation

    Percentage of time with BIS between 55 and 75 (BIS(55-75))

    6 hours

Secondary Outcomes (14)

  • Period of too deep sedation

    6 hours

  • Period of too light sedation

    6 hours

  • Incidence of Burst Suppression (bsr) during sedation

    6 hours

  • Level of sedation

    6 hours

  • Level of pain during sedation

    6 hours

  • +9 more secondary outcomes

Study Arms (2)

Automated postoperative sedation

EXPERIMENTAL

Automated administration of Propofol and Remifentanil.

Device: EasyTiva (algorithm is the property of Medsteer SAS)Drug: PropofolDrug: Remifentanil

Manual postoperative sedation

ACTIVE COMPARATOR

Manual administration of Propofol and Remifentanil.

Drug: PropofolDrug: Remifentanil

Interventions

PropofolDRUG

The dosage is modified automatically by the device or according to the new medical prescription.

Automated postoperative sedationManual postoperative sedation
RemifentanilDRUG

The dosage is modified automatically by the device or according to the new medical prescription.

Automated postoperative sedationManual postoperative sedation
EasyTiva (algorithm is the property of Medsteer SAS)DEVICE

Propofol and Remifentanil are administered automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 55 and 75.

Automated postoperative sedation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac surgical procedure requiring postoperative sedation
  • Low operative risk : EuroSCORE 2 ≤ 5%
  • Consent for participation
  • Affiliation to the social security system

You may not qualify if:

  • Pregnant or breastfeeding women
  • Neurological or muscular disorder
  • Pacemaker
  • Hypersensitivity to propofol or remifentanil
  • Communication difficulties or neuropsychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Related Publications (2)

  • Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

    PMID: 21233500RESULT

  • Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.

    PMID: 23223772RESULT

MeSH Terms

Interventions

PropofolRemifentanil

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thierry Chazot, MD

    Hôpital FOCH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 7, 2018

Study Start

December 17, 2018

Primary Completion

March 28, 2019

Study Completion

March 30, 2019

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)