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

Total Knee Replacement Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036736
• Other study ID #: P120702
• Secondary ID: 2012-005270-61
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2014
• Last updated: December 19, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• 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

Clinical Trial 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.

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

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Orthopedic Surgery
• Total Hip Prosthesis
• Total Knee Replacement

Intervention

Drug:
• Intraoperative anesthetic strategy by Propofol
1- 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
• Intraoperative anesthetic strategy by Desflurane
2- 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

Locations

Country	Name	City	State
France	Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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