Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02036736
Acronym
Cognides
Enrollment
60
Registered
2014-01-15
Start date
2013-04-30
Completion date
2014-12-31
Last updated
2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Surgery, Total Hip Prosthesis, Total Knee Replacement

Keywords

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

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

Interventions

DRUGIntraoperative 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

DRUGIntraoperative 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)1 dayCompare 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

MeasureTime frame
proportion of patients with nausea and vomiting1 day
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 patient satisfaction on a visual analogue scale in room post-interventional monitoring1 day
Evaluate postoperative pain in room post-interventional monitoring1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026