Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT04087668
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Anesthetic Technique For ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D019148', 'term': 'Neuromuscular Blockade'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-09-11', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall complication rate', 'timeFrame': 'within 72 hours of ERCP', 'description': 'The primary outcome was the overall pulmonary and cardiac complication rate.'}], 'secondaryOutcomes': [{'measure': 'Conversion to GA', 'timeFrame': 'During the procedure', 'description': 'Conversion to general anesthesia'}, {'measure': 'Temporary interruption rate of ERCP', 'timeFrame': 'During the procedure'}, {'measure': 'Premature termination rate of ERCP', 'timeFrame': 'During the procedure'}, {'measure': 'Procedural failure rate of ERCP', 'timeFrame': 'During the procedure'}, {'measure': 'Procedure time', 'timeFrame': 'During the procedure'}, {'measure': 'Anesthesia time', 'timeFrame': 'During the procedure'}, {'measure': 'Room time', 'timeFrame': 'During the procedure', 'description': 'Patient room-in to room-out time in the ERCP suite ("room time").'}, {'measure': 'Immediate Adverse Events', 'timeFrame': 'within 24 hours of ERCP'}, {'measure': 'Delayed Adverse Events', 'timeFrame': 'within 72 hours of ERCP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'General anesthesia', 'Endoscopy', 'MAC'], 'conditions': ['Anesthesia; Adverse Effect']}, 'referencesModule': {'references': [{'pmid': '26825562', 'type': 'BACKGROUND', 'citation': 'Smith A, Silvestro L, Rodriguez RE, Austin PN. Evidence-Based Selection of Sedation Agents for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Gastroenterol Nurs. 2016 Jan-Feb;39(1):32-41. doi: 10.1097/SGA.0000000000000195.'}, {'pmid': '26825844', 'type': 'BACKGROUND', 'citation': 'Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29.'}, {'pmid': '23877477', 'type': 'BACKGROUND', 'citation': 'Barnett SR, Berzin T, Sanaka S, Pleskow D, Sawhney M, Chuttani R. Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci. 2013 Nov;58(11):3287-92. doi: 10.1007/s10620-013-2783-x. Epub 2013 Jul 23.'}, {'pmid': '8431342', 'type': 'BACKGROUND', 'citation': 'Coghlan SF, McDonald PF, Csepregi G. Use of alfentanil with propofol for nasotracheal intubation without neuromuscular block. Br J Anaesth. 1993 Jan;70(1):89-91. doi: 10.1093/bja/70.1.89.'}, {'pmid': '9924229', 'type': 'BACKGROUND', 'citation': 'Grant S, Noble S, Woods A, Murdoch J, Davidson A. Assessment of intubating conditions in adults after induction with propofol and varying doses of remifentanil. Br J Anaesth. 1998 Oct;81(4):540-3. doi: 10.1093/bja/81.4.540.'}, {'pmid': '12560298', 'type': 'BACKGROUND', 'citation': 'Erhan E, Ugur G, Gunusen I, Alper I, Ozyar B. Propofol - not thiopental or etomidate - with remifentanil provides adequate intubating conditions in the absence of neuromuscular blockade. Can J Anaesth. 2003 Feb;50(2):108-15. doi: 10.1007/BF03017840.'}, {'pmid': '10757583', 'type': 'BACKGROUND', 'citation': 'Klemola UM, Mennander S, Saarnivaara L. Tracheal intubation without the use of muscle relaxants: remifentanil or alfentanil in combination with propofol. Acta Anaesthesiol Scand. 2000 Apr;44(4):465-9. doi: 10.1034/j.1399-6576.2000.440419.x.'}]}, 'descriptionModule': {'briefSummary': 'Providing the appropriate anesthetic technique for endoscopic retrograde cholangiopancreatography (ERCP) in remote locations can be challenging. The aim of this study was therefore to prospectively assess and compare the feasibility of monitored anesthesia care (MAC) with propofol based deep sedation, standard general anesthesia and general anesthesia without neuromuscular blockade in patients undergoing ERCP.', 'detailedDescription': 'ERCP is identified as one of the most invasive endoscopic procedures, during which patients may experience anxiety, discomfort and suffer different degree of pain. So, anesthesia and analgesia are essential for this invasive procedure, especially therapeutic ERCPs. Thus, we compared the efficacy of using monitored anesthesia care (MAC) with deep sedation versus general anesthesia (GA) to perform this procedure and the incidence of complications associated with these methods of anesthesia.\n\nPrevious studies have concluded that intubation is possible without the use of neuromuscular blockade. We assume that the use of propofol and adjuvants short-acting opioids may provide adequate conditions for tracheal intubation. It was also hypothesized that it may also be useful in facilitating ERCP under general anesthesia without neuromuscular blockade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-70 years old\n* Grade Ⅰ and Ⅲ according to physical status classification system of the American Society of Anesthesiologists (ASA)\n* Coagulation function tests in normal range\n\nExclusion Criteria:\n\n* Potentially difficult airways\n* Administration of sedative or narcotic drugs in the previous 24 hours\n* Severe renal or hepatic impairment\n* Severe cardiopulmonary comorbidities (defined as American Society of Anesthesiologists physical status IV or greater)\n* Contraindications to a nasotracheal intubation\n* Coagulopathy\n* History of frequent episodes of epistaxis\n* Emergent ERCP\n* At risk for reflux and aspiration'}, 'identificationModule': {'nctId': 'NCT04087668', 'briefTitle': 'Different Anesthetic Technique For ERCP', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography', 'orgStudyIdInfo': {'id': '2019-SR-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Monitored Anesthesia Care', 'description': 'Patients in this arm will undergo an ERCP using monitored anesthesia care (MAC) with propofol based deep sedation.', 'interventionNames': ['Procedure: Monitored Anesthesia Care']}, {'type': 'OTHER', 'label': 'General Anesthesia', 'description': 'Patients in this arm will receive standard general anesthesia with neuromuscular blockade.', 'interventionNames': ['Procedure: General Anesthesia']}, {'type': 'OTHER', 'label': 'General Anesthesia Without Neuromuscular Blockade', 'description': 'Patients in this arm will receive nasotracheal intubation without neuromuscular blockade.', 'interventionNames': ['Procedure: Induction Without Neuromuscular Blockade']}], 'interventions': [{'name': 'Monitored Anesthesia Care', 'type': 'PROCEDURE', 'description': 'MAC was induced and maintained via the continuous infusion of propofol AND remifentanil using a target-controlled infusion (TCI) pump. The appropriate level of sedation was 65 to 80 points on BIS. The adjunctive sedatives (eg, fentanyl, midazolam) was at the discretion of the anesthesia team.', 'armGroupLabels': ['Monitored Anesthesia Care']}, {'name': 'General Anesthesia', 'type': 'PROCEDURE', 'description': 'Induction was done with propofol (2 mg/kg) , cis-atracurium (0.15 mg/kg) , and fentanyl (5μg/kg). After orotracheal intubation, general anesthesia was maintained with sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min) and repetitive doses of 0.1mg atracurium per kilogram were administered. After the procedure was completed, neostigmine mixed with atropine was used as a reversal agent for the neuromuscular blockade, and the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .', 'armGroupLabels': ['General Anesthesia']}, {'name': 'Induction Without Neuromuscular Blockade', 'type': 'PROCEDURE', 'description': 'Anaesthesia was induced with propofol (2 mg/kg), remifentanil(3 ug/kg) and 2% lidocaine (1 mg/kg). Nasotracheal intubation was performed 60 s after the administration. After intubation, general anesthesia was sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min). After the procedure was completed, the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .', 'armGroupLabels': ['General Anesthesia Without Neuromuscular Blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Xiaofei Cao', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Junbei Wu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Nana Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Xiaoyang Tang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Jigang Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}