NCT00730054

Brief Summary

The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_1

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

February 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

July 6, 2011

Status Verified

August 1, 2008

Enrollment Period

3 months

First QC Date

August 6, 2008

Last Update Submit

July 3, 2011

Conditions

Acute PainRespirationSedation

Keywords

Remifentanilclonidineacute painrespirationsedationcognitive function

Outcome Measures

Primary Outcomes (1)

  • Relief of pain(VAS reduction)

    Experimental

Secondary Outcomes (4)

  • Reduction in Minute ventilation

    Experimental

  • Reduction in CO2 stimulated Minute Ventilation

    experimental

  • Reduction in BIS score

    Experimental

  • Performance on Stroop test

    Experimental

Study Arms (4)

1

ACTIVE COMPARATOR

Clonidine

Drug: Remifentanil+clonidine

2

ACTIVE COMPARATOR

Remifentanil

Drug: Remifentanil+clonidine

4

EXPERIMENTAL

Remifentanil+clonidine

Drug: Remifentanil+clonidine

3

PLACEBO COMPARATOR

Placebo

Drug: Remifentanil+clonidine

Interventions

Remifentanil+clonidineDRUG

iv Remifentanil+ iv clonidine

Also known as: Ultiva, Catapressan
1234

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Acute PainRespiratory Aspiration

Interventions

RemifentanilClonidine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolinesImidazolesAzoles

Study Officials

  • Jon B Bergmann, Ass. Prof.

    Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 8, 2008

Study Start

February 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

July 6, 2011

Record last verified: 2008-08

Locations

NO(1)