Total Knee Replacement Clinical Trial
— CognidesOfficial 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
Verified date | March 2013 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Saint Antoine | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane) | 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 |
1 day | No |
Secondary | proportion of patients with nausea and vomiting | 1 day | No | |
Secondary | 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 | No | |
Secondary | Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring | 1 day | No | |
Secondary | Evaluate postoperative pain in room post-interventional monitoring | 1 day | No |
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