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CompletedNCT02036736

Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring - COGNIDES

Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The recovery of cognitive and psychomotor functions is best performed under anesthesia after desflurane when propofol in that obtaining a Aldrete score\> 8/10 output of the allowing SSPI. The principal objective is to compare the cognitive and psychomotor status of patients recovered an Aldrete score\> 8/10 according to the anesthetic agent (propofol or desflurane) using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory (visual verbal learning test) made SSPI.

Detailed description

The day before surgery, patients sign the consent and will be randomized. Then 3 tests (Stroop test, Digit Symbol Substitution Task and visual verbal learning test) will be performed. No anxiolysis will be given to the patient. The anesthetic induction will be with IV propofol (2-3 mg / kg). The maintenance will anesthetic, desflurane by for a minimum alveolar concentration of between 2% and 6% or propofol for intravenous anesthesia user target controlled. In SSPI, the Aldrete score will be evaluated every 5min. Upon obtaining a Aldrete score\> 8/10, the day before the tests will be carried out again

Conditions

Interventions

TypeNameDescription
DRUGIntraoperative anesthetic strategy by Propofol1- Arm Propofol: Propofol TCI induction target between 2 and 6 mg / mL * Sufentanil (0.15 mg / kg intravenously (IV)) * Atracurium (0.5 mg / kg IV) Maintenance mode by Propofol TCI target between 2 and 4 micrograms / mL tune to 40 \<BIS \<60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade
DRUGIntraoperative anesthetic strategy by Desflurane2- Arm Desflurane Desflurane induction (2-3 mg / kg) * Sufentanil (0.15 mg / kg IV) * Atracurium (0.5 mg / kg IV)) Desflurane closed by maintenance target with minimal alveolar concentration (MAC) to adapt the circuit to obtain a figure 40 \<BIS \<60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade

Timeline

Start date
2013-04-01
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2014-01-15
Last updated
2014-12-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02036736. Inclusion in this directory is not an endorsement.