Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

Sponsor

Hopital Foch (Other)

Overall Status

Completed

CT.gov ID

NCT00921284

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: NaCl 9/00 Drug: dexmedetomidine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo	Drug: NaCl 9/00 Same volume as in the dexmedetomidine group
Experimental: dexmedetomidine patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine	Drug: dexmedetomidine 1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Drug: NaCl 9/00

Same volume as in the dexmedetomidine group

Experimental: dexmedetomidine

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

Drug: dexmedetomidine

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

Outcome Measures

Primary Outcome Measures

administered doses of propofol and of remifentanil during anesthesia [end of anesthesia]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

male patients scheduled for a general anesthesia

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Foch	Suresnes		France	92151

Sponsors and Collaborators

Hopital Foch

Investigators

Study Chair: Marc Fischler, MD, Hopital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Foch

ClinicalTrials.gov Identifier:

NCT00921284

Other Study ID Numbers:

2008/41

First Posted:

Jun 16, 2009

Last Update Posted:

Sep 23, 2016

Last Verified:

Sep 1, 2016

Additional relevant MeSH terms:

Dexmedetomidine

Study Results

No Results Posted as of Sep 23, 2016