NCT01015651

Brief Summary

The aim of the study is to assess the accuracy of a new paradigm in measuring the level of nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in response to noxious stimuli in anesthetized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

April 7, 2010

Status Verified

April 1, 2010

Enrollment Period

6 months

First QC Date

November 17, 2009

Last Update Submit

April 6, 2010

Conditions

Lumbar Surgery

Keywords

nociception, intraoperative, baroreflex

Outcome Measures

Primary Outcomes (1)

  • changes in the baroreflex in response to noxious stimuli

    intraoperative

Secondary Outcomes (1)

  • perioperative requirements in anesthetic agents.

    intraoperative

Study Arms (2)

remifentanil-2

ACTIVE COMPARATOR

In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 2 ng/ml.

Drug: remifentanil

remifentanil-4

ACTIVE COMPARATOR

In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 4 ng/ml.

Drug: remifentanil

Interventions

remifentanilDRUG

anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.

remifentanil-2

Eligibility Criteria

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

You may qualify if:

  • ASA classification I-II
  • undergoing lumbar surgery for discal hernia
  • body mass index \<30 kg/m2

You may not qualify if:

  • ASA classification III-IV
  • cardiac history that precludes RR recording : atrial fibrillation, arterial hypertension, active cardiac pacing, chronic treatment with beta-blockers, alpha-blockers, calcium-blockers and angiotensin receptors inhibitors
  • diabetes
  • regular intake of cocaine, alcohol
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean-Francois PAYEN, M.D.

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

April 7, 2010

Record last verified: 2010-04

Locations

FR(1)