NCT00772616

Brief Summary

Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:

  • in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
  • in the other group, patients will receive propofol and remifentanil both automatically administered. Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2008

Typical duration for phase_4

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

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

October 11, 2008

Last Update Submit

September 22, 2016

Conditions

Anesthesia

Keywords

AnesthesiaAnalgesiaPatient-Controlled AnalgesiaHyperalgesia

Outcome Measures

Primary Outcomes (1)

  • Dose of morphine administered during the postoperative period (patient controlled analgesia)

    48 postoperative hours

Secondary Outcomes (3)

  • postoperative pain scores

    48 postoperative hours

  • postoperative hyperalgesia

    up to 5th to 7th postoperative days

  • nausea vomiting

    48 postoperative hours

Study Arms (2)

1

EXPERIMENTAL

Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).

Drug: Remifentanil

2

ACTIVE COMPARATOR

Patients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria

Drug: Sufentanil

Interventions

RemifentanilDRUG

closed-loop administration using bispectral index as the single input for the controller.

1
SufentanilDRUG

dosage according to usual criteria

2

Eligibility Criteria

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

You may qualify if:

  • \- Patients scheduled for an abdominal surgery

You may not qualify if:

  • Age less than 18 years,
  • Pregnant women,
  • Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,
  • Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
  • Inflammatory bowel disease,
  • Chronic pain,
  • Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
  • Alcoholic patients and patients taking opiates,
  • History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (2)

  • Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.

    PMID: 15983467BACKGROUND

  • Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

    PMID: 16571963BACKGROUND

MeSH Terms

Conditions

AgnosiaHyperalgesia

Interventions

RemifentanilSufentanil

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation Disorders

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFentanyl

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2008

First Posted

October 15, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(1)