Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-09 @ 10:14 AM
Study NCT ID:
NCT03705728
Status:
UNKNOWN
Last Update Posted:
2018-10-18
First Post:
2018-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Administration of Intravenous Compared With Inhalatory Anesthesia on the Occurrence of Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia', 'timeFrame': 'Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively', 'description': 'occurrence of POD as measured by the Nursing Delirium Screening Scale\n\nThe Nursing Delirium Scale\n\nSymptom 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\n\nTotal score ≤ 2 points \\> 2 points Delirium No Yes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthesia, general', 'postoperative delirium', 'postoperative nausea and vomiting', 'elderly', 'total intravenous anesthesia', 'closed-loop anesthesia', 'EEG monitoring', 'propofol', 'remifentanil', 'sevoflurane'], 'conditions': ['Postoperative Delirium', 'Elderly Patient', 'General Anesthetic Drug Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '25535170', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19106695', 'type': 'BACKGROUND', 'citation': 'Robinson 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.'}, {'pmid': '22762316', 'type': 'BACKGROUND', 'citation': 'Saczynski 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.'}, {'pmid': '15082703', 'type': 'BACKGROUND', 'citation': 'Ely 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.'}, {'pmid': '23027226', 'type': 'BACKGROUND', 'citation': 'Chan 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.'}, {'pmid': '23539235', 'type': 'BACKGROUND', 'citation': 'Radtke 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.'}, {'pmid': '26418126', 'type': 'BACKGROUND', 'citation': 'Fritz 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.'}, {'pmid': '21233500', 'type': 'BACKGROUND', 'citation': 'Liu 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.'}, {'pmid': '21828343', 'type': 'BACKGROUND', 'citation': 'Besch 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.'}, {'pmid': '25500680', 'type': 'BACKGROUND', 'citation': 'Liu 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.'}, {'pmid': '25545655', 'type': 'BACKGROUND', 'citation': 'Orliaguet 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.'}, {'pmid': '18662642', 'type': 'BACKGROUND', 'citation': 'Liu 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nObjectives 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.\n\nThe primary aim of the present study (i.e. incidence of POD) will be assessed by the Nursing Delirium Screening Scale (NDSS).\n\nSecondary aims:\n\nSecondary 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.\n\nSecondary 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.\n\nInclusion criterion\n\nPatients will be included in the study if:\n\n* They are 60 years old or older,\n* They have given their written informed consent,\n* They have to undergo a surgical procedure of one hour or longer. Non-inclusion criterion\n\nFollowing patients will non be eligible for the current study:\n\n* Pregnant women,\n* Patients presenting a contra-indication to the monitoring of cerebral activity (i.e. intracranial surgery, neuroleptic or anti epileptic medications, pace maker),\n* Patients presenting any allergy to propofol and or remifentanil,\n* 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\n\nNumber of subjects: 1000 Number of center: 4 Duration of the research: 36 months\n\nStatistical Analysis: Sequential group analysis. The preoperative and postoperative NDSS test will be analyzed with an ANOVA for repeated-measure and multiple-comparison.\n\nThe 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\n\nDescription of the Nursing Delirium Screening Scale (NDSS) that is a validated scale to assess POD at the bedside.\n\nFive 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.\n\nThe NDSS can be rated one or more times daily.\n\nScoring information Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe.\n\nPositive NDSS is score ≥ 2, maximum total score is 10."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 59 year\n* Informed written consent before enrolment;\n* Procedure duration \\> 60 min.\n* Speaking French\n* Possible contact one-month following surgery\n\nExclusion Criteria:\n\n* Contraindication of brain monitoring (intracranial surgery), pace-maker.\n* Propofol or remifentanil allergy.\n* Patients under guardianship'}, 'identificationModule': {'nctId': 'NCT03705728', 'acronym': 'AG-DPO', 'briefTitle': 'Automated Administration of Intravenous Compared With Inhalatory Anesthesia on the Occurrence of Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Centre Clinical, France'}, 'officialTitle': 'Impact of the Automated Administration of Intravenous Anesthesia Compared to Inhalatory Anesthesia on the Speed of Emergence and the Occurrence of Postoperative Delirium', 'orgStudyIdInfo': {'id': 'AG-DPO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous group', 'description': 'Propofol \\& remifentanil administration using the closed-loop controller with the "Easy-TIVA" platfrom.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil automatic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'volatile anesthesia group', 'description': '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.', 'interventionNames': ['Drug: Sevoflurane', 'Drug: Remifentanil manual']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval', 'armGroupLabels': ['Intravenous group']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Sevoflurane will be manually administered to maintain the BIS value within the 40-60 interval', 'armGroupLabels': ['volatile anesthesia group']}, {'name': 'Remifentanil automatic', 'type': 'DRUG', 'description': 'Remifentanil will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval', 'armGroupLabels': ['Intravenous group']}, {'name': 'Remifentanil manual', 'type': 'DRUG', 'description': 'Remifentanil will be manually administered to maintain the BIS value within the 40-60 interval', 'armGroupLabels': ['volatile anesthesia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16800', 'city': 'Soyaux', 'state': 'Charente', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Paqueron, MD PhD', 'role': 'CONTACT', 'phone': '+33545979562'}, {'name': 'Thierry Chazot, MD', 'role': 'CONTACT', 'email': 'tchazot@gmail.com', 'phone': '+33629820241'}], 'facility': 'Centre Clinical', 'geoPoint': {'lat': 45.64052, 'lon': 0.19752}}], 'centralContacts': [{'name': 'Xavier Paqueron, MD PhD', 'role': 'CONTACT', 'email': 'xavier.paqueron@orange.fr', 'phone': '+33545979562'}, {'name': 'Thierry Chazot, MD', 'role': 'CONTACT', 'email': 'tchazot@gmail.com', 'phone': '+33629820241'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Clinical, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}