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

Phase 2

Completed

• Conditions: Orthopedic Surgery; Total Hip Prosthesis; Total Knee Replacement
• Interventions: Drug: Intraoperative anesthetic strategy by Propofol; Drug: Intraoperative anesthetic strategy by Desflurane

• Registration Number: NCT02036736
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-04
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane	Intraoperative anesthetic strategy by Propofol	Intraoperative anesthetic strategy by Desflurane versus Propofol
Propofol	Intraoperative anesthetic strategy by Desflurane	Intraoperative anesthetic strategy by Propofol versus Desflurane

Primary Outcome Measures

Name	Time	Method
Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)	1 day	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 test verbal memory (visual verbal learning test) made room post-interventional monitoring; The primary endpoint will be the average score of three tests in room post-interventional monitoring (Stroop test, Digit Symbol Substitution Task, Visual Verbal Learning Test) scores expressed in standard deviation

Secondary Outcome Measures

Name	Time	Method
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).	1 day
Evaluate postoperative pain in room post-interventional monitoring	1 day
proportion of patients with nausea and vomiting	1 day
Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring	1 day

Trial Locations

Locations (1)

Hôpital Saint Antoine; 🇫🇷 Paris, France