Skip to main content
Clinical Trials/NCT02036736
NCT02036736
Completed
Phase 2

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country60 target enrollmentApril 2013

Overview

Phase
Phase 2
Intervention
Intraoperative anesthetic strategy by Desflurane
Conditions
Orthopedic Surgery
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
60
Locations
1
Primary Endpoint
Compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)
Status
Completed
Last Updated
11 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Propofol

Intraoperative anesthetic strategy by Propofol versus Desflurane

Intervention: Intraoperative anesthetic strategy by Desflurane

Desflurane

Intraoperative anesthetic strategy by Desflurane versus Propofol

Intervention: Intraoperative anesthetic strategy by Propofol

Outcomes

Primary Outcomes

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

Time Frame: 1 day

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

Secondary Outcomes

  • Evaluate postoperative pain in room post-interventional monitoring(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)
  • proportion of patients with nausea and vomiting(1 day)
  • Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring(1 day)

Study Sites (1)

Loading locations...

Similar Trials