Clinical trial NCT02036736: Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring - COGNIDES
Official title: Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Orthopedic Surgery
Total Hip Prosthesis
Total Knee Replacement
Keywords: Orthopedic Surgery
Total hip prosthesis
Total knee replacement
Intraoperative anesthetic strategy
Propofol
Desflurane
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years
* ASA I, II
* General anesthesia provided
* Scheduled orthopedic surgery
* Duration of surgery between one and three hours
* Patient has given its written consent
* Patient receiving medical health insurance

Exclusion Criteria:

* MMS (Mini Mental State) ≤ 24
* Patient does not speak or read or do not understand the French
* Previous surgery within seven days
* Coronary insufficiency, renal, hepatic
* Chronic pulmonary disease
* Obesity (BMI\> 35)
* Addiction
* Chronic alcoholism
* Hematocrit \<25%
* Personal and family history of malignant hyperthermia
* Taking benzodiazepines or psychotropic within 24 hours preoperative
* Psychiatric pathology being
* Psychological or neurological disorder causing difficulties in understanding the study
* Chronic pain and / or taking analgesics 3.
* Pregnancy or breastfeeding
* Disorder of hemostasis: platelets \<80,000 / mm3, PT \<50% TCA\> 1.5 times the control.
* Hypersensitivity to propofol or desflurane or any of the excipients
* Patients allergic to soy and peanuts
* History of liver disease, jaundice, unexplained fever, eosinophilia after administration of a halogenated anesthetic
* Hypersensitivity to egg lecithin.

Primary outcomes:
measure: Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)
timeFrame: 1 day
Secondary outcomes:
measure: proportion of patients with nausea and vomiting
timeFrame: 1 day
measure: Search intraoperative factors alterations in cognitive and psychomotor functions (number of red blood cells transfused, number of hypotensive episodes (≤ 80mmHg or MAP NOT ≤ 65mmHg)≥ 10 minutes).
timeFrame: 1 day
measure: Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring
timeFrame: 1 day
measure: Evaluate postoperative pain in room post-interventional monitoring
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Antoine
Study officials:
affiliation: APHP
name: Cyrille Robert, PH
role: PRINCIPAL_INVESTIGATOR
References: