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

NCT02036736 | Completed Phase 2

• 2 other identifiers: P1207022012-005270-61
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery; Total Hip Prosthesis; Total Knee Replacement

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• proportion of patients with nausea and vomiting

  1 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 monitoring

  1 day

• Evaluate postoperative pain in room post-interventional monitoring

  1 day

Study Arms (2)

Propofol

EXPERIMENTAL

Intraoperative anesthetic strategy by Propofol versus Desflurane

Drug: Intraoperative anesthetic strategy by Desflurane

Desflurane

EXPERIMENTAL

Intraoperative anesthetic strategy by Desflurane versus Propofol

Drug: Intraoperative anesthetic strategy by Propofol

Interventions

Intraoperative anesthetic strategy by Propofol 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

Desflurane

Intraoperative anesthetic strategy by Desflurane 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

Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Antoine

Paris, Paris, 75012, France

Location

Study Officials

• Cyrille Robert, PH

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 15, 2014
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2013-03

Locations

FR (1)