Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-25 @ 6:37 AM
Study NCT ID:
NCT02361060
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2014-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2014-12-23', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in FVC at 1h after surgery', 'timeFrame': 'Basal and one hour after surgery'}], 'secondaryOutcomes': [{'measure': 'Atelectasis size determined by lung ultrasound (Plannimetry)', 'timeFrame': 'One hour after surgery'}, {'measure': 'Atelectasis size determined by lung ultrasound (Plannimetry)', 'timeFrame': '24 hours after surgery'}, {'measure': 'pO2/FiO2 <300', 'timeFrame': '1 hour after surgery'}, {'measure': 'Asociation between atelectasis size and FVC', 'timeFrame': '1 hour after surgery', 'description': 'Atelectasis size (sqr cm) will me measured by planimetry'}, {'measure': 'Asociation between atelectasis size and FVC', 'timeFrame': '24 hour after surgery', 'description': 'Atelectasis size (sqr cm) will me measured by planimetry'}, {'measure': 'Asociation between atelectasis size and pO2/FiO2', 'timeFrame': '1 hour after surgery', 'description': 'Atelectasis size (sqr cm) will me measured by planimetry'}, {'measure': 'Asociation between atelectasis size and pO2/FiO2', 'timeFrame': '24 hour after surgery', 'description': 'Atelectasis size (sqr cm) will me measured by planimetry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Abdominal Surgery']}, 'referencesModule': {'references': [{'pmid': '18385265', 'type': 'BACKGROUND', 'citation': 'Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.'}, {'pmid': '18946293', 'type': 'BACKGROUND', 'citation': 'Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.'}, {'pmid': '19387176', 'type': 'BACKGROUND', 'citation': 'Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0.'}, {'pmid': '18653492', 'type': 'BACKGROUND', 'citation': 'Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.'}, {'pmid': '19455040', 'type': 'BACKGROUND', 'citation': 'Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.'}, {'pmid': '19441874', 'type': 'BACKGROUND', 'citation': 'Yang LP, Keam SJ. Sugammadex: a review of its use in anaesthetic practice. Drugs. 2009;69(7):919-42. doi: 10.2165/00003495-200969070-00008.'}, {'pmid': '19821409', 'type': 'BACKGROUND', 'citation': 'Abrishami A, Ho J, Wong J, Yin L, Chung F. Sugammadex, a selective reversal medication for preventing postoperative residual neuromuscular blockade. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD007362. doi: 10.1002/14651858.CD007362.pub2.'}, {'pmid': '19542885', 'type': 'BACKGROUND', 'citation': 'Ferreyra G, Long Y, Ranieri VM. Respiratory complications after major surgery. Curr Opin Crit Care. 2009 Aug;15(4):342-8. doi: 10.1097/MCC.0b013e32832e0669.'}, {'pmid': '15687314', 'type': 'BACKGROUND', 'citation': 'Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM; Piedmont Intensive Care Units Network (PICUN). Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005 Feb 2;293(5):589-95. doi: 10.1001/jama.293.5.589.'}, {'pmid': '8430970', 'type': 'BACKGROUND', 'citation': 'Yu CJ, Yang PC, Wu HD, Chang DB, Kuo SH, Luh KT. Ultrasound study in unilateral hemithorax opacification. Image comparison with computed tomography. Am Rev Respir Dis. 1993 Feb;147(2):430-4. doi: 10.1164/ajrccm/147.2.430.'}, {'pmid': '20442260', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.'}, {'pmid': '22113182', 'type': 'BACKGROUND', 'citation': 'Tusman G, Bohm SH, Warner DO, Sprung J. Atelectasis and perioperative pulmonary complications in high-risk patients. Curr Opin Anaesthesiol. 2012 Feb;25(1):1-10. doi: 10.1097/ACO.0b013e32834dd1eb.'}], 'seeAlsoLinks': [{'url': 'http://dx.doi.org/10.1016/j.redar.2014.02.005', 'label': 'Sugammadex and anaphylaxis in the operating theater.'}, {'url': 'http://dx.doi.org/10.1016/j.redar.2013.11.009', 'label': 'Postoperative respiratory outcomes in laparoscopic bariatric surgery: Comparison of a prospective group of patients whose neuromuscular blockade was reverted with sugammadex and a his-torical one reverted with neostigmine'}]}, 'descriptionModule': {'briefSummary': 'Pulmonary complications are relatively frequent after surgery, and can be associated with an increase in morbidity and mortality. Although there are several causative mechanisms that can lead to postoperative pulmonary complications, alterations in the shape and motion of the chest wall are of primary importance.\n\nIn the investigator´s institution the incidence of postoperatory hypoxemia defined as pO2/FiO2 \\<300 is over 20% for patients after major abdominal surgery.\n\nObservational and randomized clinical trials have demonstrated that incomplete neuromuscular recovery during the early postoperative period may result in acute respiratory events (hypoxemia and airway obstruction) and an increased risk of postoperative pulmonary complications.\n\nA recent study in laparoscopic bariatric surgery showed that patients in which neuromuscular block reversal was done with sugammadex had less chest X-ray pathological changes than those from an historical cohort reversed with neostigmine.\n\nThe hypothesis is that differences in pulmonary complications, as atelectasis and hypoxemia, between patients reverted with sugammadex or neostigmine may be more apparent with more sensitive techniques like spirometry or lung ultrasound when they exist.\n\nLung ultrasound (LUS) has demonstrated a sensitivity of 90% and a specificity of 98%, to detect alveolar consolidation in critical ill patients while chest radiography data are known to be imprecise.The investigator would like to explore the utility of LUS in postsurgical patients and the relationship between degree of hypoxemia and consolidation area.\n\nObjectives:\n\n1. Primary: Forced vital capacity decreases after surgery. This reduction may be relieved in the absence of residual neuromuscular block. Objective is to assess differences after reversal with neostigmine versus sugammadex in:\n\n • Forced vital capacity (FVC)\n2. Secondary objectives: To assess differences after reversal with neostigmine versus sugammadex in:\n\n * Atelectasis size determined by lung ultrasound (Plannimetry)\n * pO2/FiO2 \\<300 1 hour after surgery\n * Explore the accuracy of lung ultrasound (LUS) to diagnosis postoperative atelectasis and its correlation with chest Xray, FVC and pO2/FiO2.\n\nHypotheses:\n\n1. Sugammadex NMB reversal results in a lower reduction of forced vital capacity (FVC) as compared to NMB reversal with neostigmine.\n2. Atelectasis is common after major surgery. Size of atelectasis determined by lung ultrasound planimetry is lower one hour after sugammadex reversal as compared to the neostigmine group.\n3. The incidence of post-surgical hypoxemia is lower in the sugammadex group as compared to the neostigmine group (Hypoxemia defined as pO2/FiO2 less than 300 is expected in 20% of patients after major abdominal surgery).\n4. Lung ultrasound has a better capacity to detect alveolar consolidation than Chest Xray after major surgery.\n5. Atelectasis size determine by planimetry has a good correlation with pO2/FiO2 and decrease of FVC after surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patient scheduled for major abdominal surgery (liver resection, pancreatectomy, gastrectomy or any type of colectomy) will be nominated to participate in the study.\n* Informed consent will be asked for after their admission to the hospital the day before the surgery.\n* Patients with postoperative epidural analgesia.\n\nExclusion Criteria:\n\n* Refusal to participate.\n* Entry to postoperative recovery unit under mechanical ventilation.\n* Hypersensitivity reactions to any of the drugs.\n* Severe asthma and mild asthma under treatment.\n* Myocardial infarction or coronary occlusion three months prior to surgery.\n* Myasthenia gravis.\n* Emergency surgery.\n* Pulmonary fibrosis or very severe chronic obstructive lung disease (GOLD IV)'}, 'identificationModule': {'nctId': 'NCT02361060', 'briefTitle': 'Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}, 'officialTitle': 'Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PRIN-SUGAR-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex', 'description': 'sugammadex 4 mg/kg', 'interventionNames': ['Drug: Sugammadex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neostigmine + Atropine', 'description': 'Neostigmine 40µg/kg in combination with atropine 10µg/kg.', 'interventionNames': ['Drug: Neostigmine', 'Drug: Atropine']}], 'interventions': [{'name': 'Neostigmine', 'type': 'DRUG', 'description': '40mcg/kg', 'armGroupLabels': ['Neostigmine + Atropine']}, {'name': 'Sugammadex', 'type': 'DRUG', 'description': '4mg/kg', 'armGroupLabels': ['Sugammadex']}, {'name': 'Atropine', 'type': 'DRUG', 'description': '10 mcg/kg', 'armGroupLabels': ['Neostigmine + Atropine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28006', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Anesthesiology Service. Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28006', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enrique Alday Muñoz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator.', 'investigatorFullName': 'Enrique Alday Muñoz', 'investigatorAffiliation': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}}}}