Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: NaCl 9/00; Drug: dexmedetomidine

• Registration Number: NCT00921284
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-13
• Study First Submitted QC: 2009-06-13
• Study First Posted: 2009-06-16
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• male patients scheduled for a general anesthesia

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NaCl 9/00	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
dexmedetomidine	dexmedetomidine	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine

Primary Outcome Measures

Name	Time	Method
administered doses of propofol and of remifentanil during anesthesia	end of anesthesia

Secondary Outcome Measures

Name	Time	Method
delay before recovery	at the end of anesthesia
hemodynamic abnormalities requiring a treatment	end of anesthesia
explicit memorisation	Second postoperative day
postoperative morphine requirement	Third post-anesthetic hour

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France