Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT02635802
Status:
UNKNOWN
Last Update Posted:
2015-12-21
First Post:
2015-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2015-12-06', 'studyFirstSubmitQcDate': '2015-12-16', 'lastUpdatePostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vital signs change', 'timeFrame': 'baseline, intraoperative and 10mins after operation', 'description': 'heart rate, respiration rate'}, {'measure': 'vital signs change', 'timeFrame': 'baseline, intraoperative and 10mins after operation', 'description': 'respiration rate'}, {'measure': 'vital signs change', 'timeFrame': 'baseline, intraoperative and 10mins after operation', 'description': 'blood oxygen saturation of artery blood of finger(SpO2)'}, {'measure': 'vital signs change', 'timeFrame': 'baseline, intraoperative and 10mins after operation', 'description': 'mean blood pressure'}, {'measure': 'vital signs change', 'timeFrame': 'baseline, intraoperative and 10mins after operation', 'description': 'Critical-Care Observation Tool(CPOT)'}, {'measure': 'vital signs change', 'timeFrame': 'baseline, intraoperative and 10mins after operation', 'description': 'Richmond Agitation-Sedation Scale(RASS)'}], 'secondaryOutcomes': [{'measure': 'number of adverse reaction', 'timeFrame': 'baseline,intraoperative,10mins after operation,30mins after operation', 'description': 'respiratory depression,skeletal muscle stiffness,nausea vomting and dizziness,hypertension,allergy,bradycardia etc.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['remifentanil', 'analgesia', 'intensive care units'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '9291773', 'type': 'RESULT', 'citation': 'Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. No abstract available.'}, {'pmid': '11573581', 'type': 'RESULT', 'citation': 'Soltesz S, Biedler A, Silomon M, Schopflin I, Molter GP. Recovery after remifentanil and sufentanil for analgesia and sedation of mechanically ventilated patients after trauma or major surgery. Br J Anaesth. 2001 Jun;86(6):763-8. doi: 10.1093/bja/86.6.763.'}, {'pmid': '10525595', 'type': 'RESULT', 'citation': 'Wilhelm W, Dorscheid E, Schlaich N, Niederprum P, Deller D. [The use of remifentanil in critically ill patients. Clinical findings and early experience]. Anaesthesist. 1999 Sep;48(9):625-9. doi: 10.1007/s001010050762. German.'}, {'pmid': '18495056', 'type': 'RESULT', 'citation': 'Wilhelm W, Kreuer S. The place for short-acting opioids: special emphasis on remifentanil. Crit Care. 2008;12 Suppl 3(Suppl 3):S5. doi: 10.1186/cc6152. Epub 2008 May 14.'}, {'pmid': '20237760', 'type': 'RESULT', 'citation': 'Casey E, Lane A, Kuriakose D, McGeary S, Hayes N, Phelan D, Buggy D. Bolus remifentanil for chest drain removal in ICU: a randomized double-blind comparison of three modes of analgesia in post-cardiac surgical patients. Intensive Care Med. 2010 Aug;36(8):1380-5. doi: 10.1007/s00134-010-1836-2. Epub 2010 Mar 18.'}, {'pmid': '23052952', 'type': 'RESULT', 'citation': 'Chalumeau-Lemoine L, Stoclin A, Billard V, Laplanche A, Raynard B, Blot F. Flexible fiberoptic bronchoscopy and remifentanil target-controlled infusion in ICU: a preliminary study. Intensive Care Med. 2013 Jan;39(1):53-8. doi: 10.1007/s00134-012-2697-7. Epub 2012 Sep 28.'}, {'pmid': '21040558', 'type': 'RESULT', 'citation': 'Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.'}, {'pmid': '21971434', 'type': 'RESULT', 'citation': 'Futier E, Chanques G, Cayot Constantin S, Vernis L, Barres A, Guerin R, Chartier C, Perbet S, Petit A, Jabaudon M, Bazin JE, Constantin JM. Influence of opioid choice on mechanical ventilation duration and ICU length of stay. Minerva Anestesiol. 2012 Jan;78(1):46-53. Epub 2011 Nov 5.'}, {'pmid': '16526829', 'type': 'RESULT', 'citation': 'Battershill AJ, Keating GM. Remifentanil : a review of its analgesic and sedative use in the intensive care unit. Drugs. 2006;66(3):365-85. doi: 10.2165/00003495-200666030-00013.'}, {'pmid': '15312228', 'type': 'RESULT', 'citation': 'Karabinis A, Mandragos K, Stergiopoulos S, Komnos A, Soukup J, Speelberg B, Kirkham AJ. Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308]. Crit Care. 2004 Aug;8(4):R268-80. doi: 10.1186/cc2896. Epub 2004 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. Remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in ICU small short time operation.The purpose of this study is to determine (1) whether remifentanil is effective in small short time operations in ICU or not, (2) the save range of remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens in these operations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill patients need endotracheal intubation\n* tracheotomy\n* central venous puncture\n* pleural puncture\n* abdominal puncture\n* lumbar puncture\n* bone marrow puncture\n* fiber bronchoscopic examination\n* other small short-time operations\n\nExclusion Criteria:\n\n* patients allergic to opioids\n* in pregnancy or in feeding\n* with myasthenia gravis\n* with hypovolemia,\n* take monoamine oxidase inhibitor(MAOI) in 14days\n* in coma and GCS\\<8\n* with bradycardia or hypotension'}, 'identificationModule': {'nctId': 'NCT02635802', 'briefTitle': 'the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation', 'orgStudyIdInfo': {'id': 'zdyfysicu-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remifentanil', 'description': 'injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time \\>1min,then 5μg/kg·h pumping until the operation is finished.', 'interventionNames': ['Drug: Remifentanil', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'injection form concentration 10mg/ml loading dose 100-400mg local anesthesia', 'interventionNames': ['Drug: Lidocaine', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Remifentanil+Lidocaine', 'description': 'injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time \\>1min,then 5μg/kg·h pumping until the operation is finished\n\n\\+ injection form concentration 10mg/ml loading dose 100-400mg local anesthesia', 'interventionNames': ['Drug: Remifentanil+Lidocaine', 'Drug: Midazolam']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'description': 'a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time \\>1min,then 5μg/kg·h pumping if the operation can not be done in 5 minutes.\n\nCritical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after the loading.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5 μg/kg·h every 2-5min.', 'armGroupLabels': ['Remifentanil']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'lidocaine 100-400mg,local anesthesia.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after local anesthesia.We should maintain the CPOT≤2 and RASS 0～2.', 'armGroupLabels': ['Lidocaine']}, {'name': 'Remifentanil+Lidocaine', 'type': 'DRUG', 'description': 'a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time \\>1min,then 5μg/kg·h remifentanil pumping immediately if the operation can not be done in 5 minutes.then local anesthesia with lidocaine 100-400mg.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after anesthesia.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5μg/kg·h every 2-5min.', 'armGroupLabels': ['Remifentanil+Lidocaine']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'midazolam is an adjuvant drug.we should maintain the CPOT≤2 and RASS 0～2,if lidocaine is already used up to 400mg or the pumping rate of remifentanil is already 7.5μg/kg·h,then we should use midazolam 3mg, intravenous injection slowly.', 'armGroupLabels': ['Lidocaine', 'Remifentanil', 'Remifentanil+Lidocaine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yichang Humanwell Pharmaceutical Co., Ltd., China', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The director of SICU,Chief physician,professor', 'investigatorFullName': 'Rongqi Sun', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}