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Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00921284
Enrollment
66
Registered
2009-06-16
Start date
2009-06-30
Completion date
2011-07-31
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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

Interventions

Same volume as in the dexmedetomidine group

DRUGdexmedetomidine

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

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
administered doses of propofol and of remifentanil during anesthesiaend of anesthesia

Secondary

MeasureTime frame
delay before recoveryat the end of anesthesia
hemodynamic abnormalities requiring a treatmentend of anesthesia
postoperative morphine requirementThird post-anesthetic hour
explicit memorisationSecond postoperative day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026