NCT00921284

Brief Summary

The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

June 13, 2009

Last Update Submit

September 22, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • administered doses of propofol and of remifentanil during anesthesia

    end of anesthesia

Secondary Outcomes (4)

  • delay before recovery

    at the end of anesthesia

  • hemodynamic abnormalities requiring a treatment

    end of anesthesia

  • postoperative morphine requirement

    Third post-anesthetic hour

  • explicit memorisation

    Second postoperative day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo

Drug: NaCl 9/00

dexmedetomidine

EXPERIMENTAL

patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine

Drug: dexmedetomidine

Interventions

NaCl 9/00DRUG

Same volume as in the dexmedetomidine group

Placebo
dexmedetomidineDRUG

1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr

dexmedetomidine

Eligibility Criteria

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

You may qualify if:

  • male patients scheduled for a general anesthesia

You may not qualify if:

  • age lower than 18 years
  • allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine,or to a myorelaxant or to an excipient,
  • hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
  • history of central nervous system disease,
  • patients receiving a psychotropic treatment or an agonist-antagonist opiate,
  • hypovolemic patients,
  • patients receiving a cardio-vascular treatment,
  • expected bleeding surgical procedure,
  • simultaneous general and loco-regional anesthesia,
  • severe hepatic insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, 92151, France

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2009

First Posted

June 16, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(1)