Orthopedic SurgeryPhase 2CognidesNCT02036736
Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring - COGNIDES
A Phase 2 study testing Intraoperative anesthetic strategy by Propofol and Intraoperative anesthetic strategy by Desflurane in people with Orthopedic Surgery and Total Hip Prosthesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic Surgery, Total Hip Prosthesis, Total Knee Replacement
- What is being tested?
- Intraoperative anesthetic strategy by Propofol and Intraoperative anesthetic strategy by Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring
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.
Read the 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
- Being tested
- Intraoperative anesthetic strategy by Propofol, Intraoperative anesthetic strategy by Desflurane
- Keywords
- Orthopedic Surgery, Total hip prosthesis, Total knee replacement, Intraoperative anesthetic strategy, Propofol, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative anesthetic strategy by PropofolDrug
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
Intraoperative anesthetic strategy by DesfluraneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Intraoperative anesthetic strategy by Propofol versus Desflurane Receives: Drug: Intraoperative anesthetic strategy by Desflurane |
| Desflurane | Experimental | Intraoperative anesthetic strategy by Desflurane versus Propofol Receives: Drug: Intraoperative anesthetic strategy by Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (4)
proportion of patients with nausea and vomiting
Measured: 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).
Measured: 1 day
Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring
Measured: 1 day
Evaluate postoperative pain in room post-interventional monitoring
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrille Robert, PH, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036736
- Sponsor's protocol ID
- P120702
- Other IDs
- 2012-005270-61
- Acronym
- Cognides
- Status last verified
- Mar 2013
- First submitted
- 8 Jan 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring
- ClinicalTrials.gov ID
- NCT02036736
- Acronym / sponsor ID
- Cognides / P120702
- Keywords
- Orthopedic Surgery, Total hip prosthesis, Total knee replacement, Intraoperative anesthetic strategy, Propofol, Desflurane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Intraoperative anesthetic strategy by DesfluraneIntraoperative anesthetic strategy by Propofol versus Desflurane |
| Desflurane | Experimental | Drug: Intraoperative anesthetic strategy by PropofolIntraoperative anesthetic strategy by Desflurane versus Propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and ≤ 80 years
- ASA I, II
- General anesthesia provided
- Scheduled orthopedic surgery
- Duration of surgery between one and three hours
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative anesthetic strategy by Propofol1- 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 | Drug | Desflurane |
| Intraoperative anesthetic strategy by Desflurane2- 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 | Drug | Propofol |
Primary outcome
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
4 secondary outcomes
proportion of patients with nausea and vomiting
Time frame: 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).
Time frame: 1 day
Evaluate patient satisfaction on a visual analogue scale in room post-interventional monitoring
Time frame: 1 day
Evaluate postoperative pain in room post-interventional monitoring
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyrille Robert, PH principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intraoperative anesthetic strategy by Propofol and Intraoperative anesthetic strategy by Desflurane in people with Orthopedic Surgery and Total Hip Prosthesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.