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

NCT ID: NCT02036736

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-12-31

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

Conditions

Orthopedic Surgery; Total Hip Prosthesis; Total Knee Replacement

Keywords

Orthopedic Surgery; Total hip prosthesis; Total knee replacement; Intraoperative anesthetic strategy; Propofol; Desflurane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Propofol

Intraoperative anesthetic strategy by Propofol versus Desflurane

Group Type: EXPERIMENTAL

Intraoperative anesthetic strategy by Desflurane

Intervention Type: DRUG

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

Desflurane

Intraoperative anesthetic strategy by Desflurane versus Propofol

Group Type: EXPERIMENTAL

Intraoperative anesthetic strategy by Propofol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyrille Robert, PH

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Hôpital Saint Antoine

Paris, Paris, France

Countries

France

Other Identifiers

2012-005270-61

Identifier Type: OTHER

Identifier Source: secondary_id

P120702

Identifier Type: -

Identifier Source: org_study_id