Postoperative DeliriumAG-DPONCT03705728
Automated Administration of Intravenous Compared With Inhalatory Anesthesia on the Occurrence of Postoperative Delirium
A study testing Propofol, Sevoflurane and Remifentanil automatic in people with Postoperative Delirium and Elderly Patient, run by Centre Clinical, France at 1 site in France.
Trial summary
The intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium, Elderly Patient, General Anesthetic Drug Adverse Reaction
- What is being tested?
- Propofol, Sevoflurane and Remifentanil automatic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2018to Dec 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 59 year
- Informed written consent before enrolment;
- Procedure duration > 60 min.
- Speaking French
- Possible contact one-month following surgery
Who cannot join
- Contraindication of brain monitoring (intracranial surgery), pace-maker.
- Propofol or remifentanil allergy.
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Clinical
Soyaux, Charente, 16800
Xavier Paqueron, MD PhD, +33545979562
Thierry Chazot, MD, +33629820241, tchazot@gmail.com
About this study
Official title: Impact of the Automated Administration of Intravenous Anesthesia Compared to Inhalatory Anesthesia on the Speed of Emergence and the Occurrence of Postoperative Delirium
The intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia.
Read the detailed description
Scientific background Postoperative delirium (POD) is a common complication occurring in 5 to 50 % of elderly patients following an operation. Delirium is a serious complication leading to many medical as well as social and economical consequences. Several studies suggest that, both, the choice of anesthetic agents and the conduction of anesthesia might decrease the incidence of POD.
Objectives Study goal and primary aim: the intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of POD, compared with an inhalational anesthesia.
The primary aim of the present study (i.e. incidence of POD) will be assessed by the Nursing Delirium Screening Scale (NDSS).
Secondary aims:
Secondary aim 1: Assessment of a potential difference on the incidence of PONV between the 2 groups of patients (i.e. intravenous vs. inhaled) by comparison of the number of episodes of nausea and vomiting and the need to treat this complications, between both groups.
Secondary aim 2: study if the difference of in the impairment of cognitive function might be correlated either with the type of drugs used to conduct anesthesia or with the control the index of cerebral activity (i.e. the BIS). The respective influences of the control of the index of cerebral activity (i.e. the BIS) and of the anesthetic drugs on the occurrence of postoperative cognitive dysfunctions (POCD) will be assessed by comparing cognitive function tests on matched groups on the percentage of time spent in different ranges of values of the cortical index Population of patients Patients of 60 years old or more, having given their written informed consent and who should undergo a surgical procedure of at least one hour.
Inclusion criterion
Patients will be included in the study if:
- They are 60 years old or older,
- They have given their written informed consent,
- They have to undergo a surgical procedure of one hour or longer. Non-inclusion criterion
Following patients will non be eligible for the current study:
- Pregnant women,
- Patients presenting a contra-indication to the monitoring of cerebral activity (i.e. intracranial surgery, neuroleptic or anti epileptic medications, pace maker),
- Patients presenting any allergy to propofol and or remifentanil,
- Patients under guardianship. Experimental protocol Information and inclusion of patients during the preoperative anesthetic assessment consultation First assessment of the NDSS at patient arrival in the operating room Randomization prior to the induction on the anesthesia Second NDSS just before patient leaving of PACU Recording of all PONV event as well as any administration of anti emetic drug
Number of subjects: 1000 Number of center: 4 Duration of the research: 36 months
Statistical Analysis: Sequential group analysis. The preoperative and postoperative NDSS test will be analyzed with an ANOVA for repeated-measure and multiple-comparison.
The main criterion will be analyzed with a Kaplan-Meier survival analysis on the global data and with a Cox regression that will take into account the qualitative factors represented by the type of anesthesia
Description of the Nursing Delirium Screening Scale (NDSS) that is a validated scale to assess POD at the bedside.
Five areas are assessed: disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation Description A screening tool designed for nurses to use at the end of their shift to identify patients with delirium, derived from the Confusion Rating Scale (CRS). Raters reference behaviors that they have witnessed in the patient or that the patient'snurse has witnessed during their shift to score the NDSS.
The NDSS can be rated one or more times daily.
Scoring information Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe.
Positive NDSS is score ≥ 2, maximum total score is 10.
- Being tested
- Propofol, Sevoflurane, Remifentanil automatic, Remifentanil manual
- Keywords
- anesthesia, general, postoperative delirium, postoperative nausea and vomiting, elderly, total intravenous anesthesia, closed-loop anesthesia, EEG monitoring, propofol, remifentanil, sevoflurane
- Medical subject headings
- Emergence Delirium, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval
SevofluraneDrug
Sevoflurane will be manually administered to maintain the BIS value within the 40-60 interval
Remifentanil automaticDrug
Remifentanil will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval
Remifentanil manualDrug
Remifentanil will be manually administered to maintain the BIS value within the 40-60 interval
| Study group | Role | What they receive |
|---|---|---|
| Intravenous group | Experimental | Propofol \& remifentanil administration using the closed-loop controller with the "Easy-TIVA" platfrom. Receives: Drug: Propofol; Drug: Remifentanil automatic |
| volatile anesthesia group | Active comparator | Sevoflurane will be administered manually according to the BIS values. Remifentanil will be administered manually using a Target Controlled Infusion pump using the Minto model. Receives: Drug: Sevoflurane; Drug: Remifentanil manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia
occurrence of POD as measured by the Nursing Delirium Screening Scale
The Nursing Delirium Scale
Symptom Symptom rating Disorientation 0 points 1 point 2 points Inappropriate behavior 0 points 1 point 2 points Inappropriate communication 0 points 1 point 2 points Illusion/hallucination 0 points 1 point 2 points Psychomotot retardation 0 points 1 point 2 points
Total score ≤ 2 points > 2 points Delirium No Yes
Measured: Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start30 May 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Clinical, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705728
- Sponsor's protocol ID
- AG-DPO
- Acronym
- AG-DPO
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
PubMed 25535170Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776.
PubMed 19106695Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
PubMed 22762316Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
PubMed 23027226Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.
PubMed 23539235Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
PubMed 26418126Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
PubMed 21233500Besch G, Liu N, Samain E, Pericard C, Boichut N, Mercier M, Chazot T, Pili-Floury S. Occurrence of and risk factors for electroencephalogram burst suppression during propofol-remifentanil anaesthesia. Br J Anaesth. 2011 Nov;107(5):749-56. doi: 10.1093/bja/aer235. Epub 2011 Aug 8.
PubMed 21828343Liu N, Lory C, Assenzo V, Cocard V, Chazot T, Le Guen M, Sessler DI, Journois D, Fischler M. Feasibility of closed-loop co-administration of propofol and remifentanil guided by the bispectral index in obese patients: a prospective cohort comparison. Br J Anaesth. 2015 Apr;114(4):605-14. doi: 10.1093/bja/aeu401. Epub 2014 Dec 10.
PubMed 25500680Orliaguet GA, Benabbes Lambert F, Chazot T, Glasman P, Fischler M, Liu N. Feasibility of closed-loop titration of propofol and remifentanil guided by the bispectral monitor in pediatric and adolescent patients: a prospective randomized study. Anesthesiology. 2015 Apr;122(4):759-67. doi: 10.1097/ALN.0000000000000577.
PubMed 25545655Liu N, Chazot T, Trillat B, Michel-Cherqui M, Marandon JY, Law-Koune JD, Rives B, Fischler M; Foch Lung Transplant Group. Closed-loop control of consciousness during lung transplantation: an observational study. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):611-5. doi: 10.1053/j.jvca.2008.04.022. Epub 2008 Jun 25.
PubMed 18662642
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Automated Administration of Intravenous Anesthesia Compared to Inhalatory Anesthesia on the Speed of Emergence and the Occurrence of Postoperative Delirium
- ClinicalTrials.gov ID
- NCT03705728
- Acronym / sponsor ID
- AG-DPO / AG-DPO
- Keywords
- anesthesia, general, postoperative delirium, postoperative nausea and vomiting, elderly, total intravenous anesthesia, closed-loop anesthesia, EEG monitoring, propofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Clinical, FranceUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Oct 2018 (actual)
- 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 intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia.
Detailed description
Scientific background Postoperative delirium (POD) is a common complication occurring in 5 to 50 % of elderly patients following an operation. Delirium is a serious complication leading to many medical as well as social and economical consequences. Several studies suggest that, both, the choice of anesthetic agents and the conduction of anesthesia might decrease the incidence of POD.
Objectives Study goal and primary aim: the intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of POD, compared with an inhalational anesthesia.
The primary aim of the present study (i.e. incidence of POD) will be assessed by the Nursing Delirium Screening Scale (NDSS).
Secondary aims:
Secondary aim 1: Assessment of a potential difference on the incidence of PONV between the 2 groups of patients (i.e. intravenous vs. inhaled) by comparison of the number of episodes of nausea and vomiting and the need to treat this complications, between both groups.
Secondary aim 2: study if the difference of in the impairment of cognitive function might be correlated either with the type of drugs used to conduct anesthesia or with the control the index of cerebral activity (i.e. the BIS). The respective influences of the control of the index of cerebral activity (i.e. the BIS) and of the anesthetic drugs on the occurrence of postoperative cognitive dysfunctions (POCD) will be assessed by comparing cognitive function tests on matched groups on the percentage of time spent in different ranges of values of the cortical index Population of patients Patients of 60 years old or more, having given their written informed consent and who should undergo a surgical procedure of at least one hour.
Inclusion criterion
Patients will be included in the study if:
- They are 60 years old or older,
- They have given their written informed consent,
- They have to undergo a surgical procedure of one hour or longer. Non-inclusion criterion
Following patients will non be eligible for the current study:
- Pregnant women,
- Patients presenting a contra-indication to the monitoring of cerebral activity (i.e. intracranial surgery, neuroleptic or anti epileptic medications, pace maker),
- Patients presenting any allergy to propofol and or remifentanil,
- Patients under guardianship. Experimental protocol Information and inclusion of patients during the preoperative anesthetic assessment consultation First assessment of the NDSS at patient arrival in the operating room Randomization prior to the induction on the anesthesia Second NDSS just before patient leaving of PACU Recording of all PONV event as well as any administration of anti emetic drug
Number of subjects: 1000 Number of center: 4 Duration of the research: 36 months
Statistical Analysis: Sequential group analysis. The preoperative and postoperative NDSS test will be analyzed with an ANOVA for repeated-measure and multiple-comparison.
The main criterion will be analyzed with a Kaplan-Meier survival analysis on the global data and with a Cox regression that will take into account the qualitative factors represented by the type of anesthesia
Description of the Nursing Delirium Screening Scale (NDSS) that is a validated scale to assess POD at the bedside.
Five areas are assessed: disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation Description A screening tool designed for nurses to use at the end of their shift to identify patients with delirium, derived from the Confusion Rating Scale (CRS). Raters reference behaviors that they have witnessed in the patient or that the patient'snurse has witnessed during their shift to score the NDSS.
The NDSS can be rated one or more times daily.
Scoring information Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe.
Positive NDSS is score ≥ 2, maximum total score is 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- prospective randomized
| Arm | Type | Receives |
|---|---|---|
| Intravenous group | Experimental | Drug: Propofol, Drug: Remifentanil automaticPropofol \& remifentanil administration using the closed-loop controller with the "Easy-TIVA" platfrom. |
| volatile anesthesia group | Active comparator | Drug: Sevoflurane, Drug: Remifentanil manualSevoflurane will be administered manually according to the BIS values. Remifentanil will be administered manually using a Target Controlled Infusion pump using the Minto model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 59 year
- Informed written consent before enrolment;
- Procedure duration > 60 min.
- Speaking French
- Possible contact one-month following surgery
Key exclusion criteria (3 listed)
- Contraindication of brain monitoring (intracranial surgery), pace-maker.
- Propofol or remifentanil allergy.
- Patients under guardianship
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 |
|---|---|---|
| PropofolPropofol will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval | Drug | Intravenous group |
| SevofluraneSevoflurane will be manually administered to maintain the BIS value within the 40-60 interval | Drug | volatile anesthesia group |
| Remifentanil automaticRemifentanil will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval | Drug | Intravenous group |
| Remifentanil manualRemifentanil will be manually administered to maintain the BIS value within the 40-60 interval | Drug | volatile anesthesia group |
Primary outcome
Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia
Time frame: Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively
occurrence of POD as measured by the Nursing Delirium Screening Scale The Nursing Delirium Scale Symptom Symptom rating Disorientation 0 points 1 point 2 points Inappropriate behavior 0 points 1 point 2 points Inappropriate communication 0 points 1 point 2 points Illusion/hallucination 0 points 1 point 2 points Psychomotot retardation 0 points 1 point 2 points Total score ≤ 2 points > 2 points Delirium No Yes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Background: PubMed 25535170American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
- Background: PubMed 19106695Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776.
- Background: PubMed 22762316Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Background: PubMed 23027226Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
- Background: PubMed 23539235Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.
- Background: PubMed 26418126Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.
- Background: PubMed 21233500Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
- Background: PubMed 21828343Besch G, Liu N, Samain E, Pericard C, Boichut N, Mercier M, Chazot T, Pili-Floury S. Occurrence of and risk factors for electroencephalogram burst suppression during propofol-remifentanil anaesthesia. Br J Anaesth. 2011 Nov;107(5):749-56. doi: 10.1093/bja/aer235. Epub 2011 Aug 8.
- Background: PubMed 25500680Liu N, Lory C, Assenzo V, Cocard V, Chazot T, Le Guen M, Sessler DI, Journois D, Fischler M. Feasibility of closed-loop co-administration of propofol and remifentanil guided by the bispectral index in obese patients: a prospective cohort comparison. Br J Anaesth. 2015 Apr;114(4):605-14. doi: 10.1093/bja/aeu401. Epub 2014 Dec 10.
- Background: PubMed 25545655Orliaguet GA, Benabbes Lambert F, Chazot T, Glasman P, Fischler M, Liu N. Feasibility of closed-loop titration of propofol and remifentanil guided by the bispectral monitor in pediatric and adolescent patients: a prospective randomized study. Anesthesiology. 2015 Apr;122(4):759-67. doi: 10.1097/ALN.0000000000000577.
- Background: PubMed 18662642Liu N, Chazot T, Trillat B, Michel-Cherqui M, Marandon JY, Law-Koune JD, Rives B, Fischler M; Foch Lung Transplant Group. Closed-loop control of consciousness during lung transplantation: an observational study. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):611-5. doi: 10.1053/j.jvca.2008.04.022. Epub 2008 Jun 25.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol, Sevoflurane and Remifentanil automatic in people with Postoperative Delirium and Elderly Patient, run by Centre Clinical, France 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Paqueron, MD PhD (+33545979562, xavier.paqueron@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia (time frame: Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705728, which also lists 12 linked publications.
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 18 Oct 2018.