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

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed
Phase 2

Conditions

Orthopedic Surgery
Total Hip Prosthesis
Total Knee Replacement

Treatments

Drug: Intraoperative anesthetic strategy by Propofol
Drug: Intraoperative anesthetic strategy by Desflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT02036736
P120702
2012-005270-61 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Propofol
Experimental group
Description:
Intraoperative anesthetic strategy by Propofol versus Desflurane
Treatment:
Drug: Intraoperative anesthetic strategy by Desflurane
Desflurane
Experimental group
Description:
Intraoperative anesthetic strategy by Desflurane versus Propofol
Treatment:
Drug: Intraoperative anesthetic strategy by Propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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