Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-29 @ 2:46 PM
Study NCT ID:
NCT04236050
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Infusion and Bolus Doses of Rocuronium During Lumbal Discectomy, Muscle Strength and Patient Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-19', 'studyFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2020-01-19', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle strength', 'timeFrame': 'perioperative', 'description': 'Change in muscle strength between groups measured my hand-grip dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.'}, {'measure': 'Change in quality of patient recovery', 'timeFrame': 'up to 24 weeks', 'description': 'Change in quality of recovery between groups measured with Qor-40 questionnaire.\n\nThe quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery.'}], 'secondaryOutcomes': [{'measure': 'Validation of Croatian version of the quality of recovery questionnaire (Qor-40)', 'timeFrame': 'perioperative', 'description': 'Translate to croatian language the quality of recovery questionnaire according to Beaton and Bullinger docrtine and evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice in croatian speaking area'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rocuronium', 'Qor-40', 'lumbar discectomy', 'muscle strength'], 'conditions': ['Rocuronium', 'Lumbar Discectomy', 'Recovery']}, 'referencesModule': {'references': [{'pmid': '28573344', 'type': 'RESULT', 'citation': 'Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. German.'}, {'pmid': '11753022', 'type': 'RESULT', 'citation': 'Naguib M, Flood P, McArdle JJ, Brenner HR. Advances in neurobiology of the neuromuscular junction: implications for the anesthesiologist. Anesthesiology. 2002 Jan;96(1):202-31. doi: 10.1097/00000542-200201000-00035. No abstract available.'}, {'pmid': '19468024', 'type': 'RESULT', 'citation': 'Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24.'}, {'pmid': '11049917', 'type': 'RESULT', 'citation': 'Jellish WS, Brody M, Sawicki K, Slogoff S. Recovery from neuromuscular blockade after either bolus and prolonged infusions of cisatracurium or rocuronium using either isoflurane or propofol-based anesthetics. Anesth Analg. 2000 Nov;91(5):1250-5. doi: 10.1097/00000539-200011000-00037.'}, {'pmid': '20236270', 'type': 'RESULT', 'citation': 'Sweeney BP. Neuromuscular blockade and minimal monitoring. Anaesthesia. 2010 Mar;65(3):308. doi: 10.1111/j.1365-2044.2010.06252.x. No abstract available.'}, {'pmid': '11942873', 'type': 'RESULT', 'citation': 'Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x.'}, {'pmid': '22791040', 'type': 'RESULT', 'citation': 'Desai A, Bekelis K, Ball PA, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Spine patient outcomes research trial: do outcomes vary across centers for surgery for lumbar disc herniation? Neurosurgery. 2012 Oct;71(4):833-42. doi: 10.1227/NEU.0b013e31826772cb.'}, {'pmid': '10740540', 'type': 'RESULT', 'citation': 'Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.'}, {'pmid': '14576554', 'type': 'RESULT', 'citation': 'Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.'}]}, 'descriptionModule': {'briefSummary': 'The continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.', 'detailedDescription': 'Rocuronium is a non-depolarising neuromuscular blocking agent that can be administered in bolus doses or via continuous infusion during general anesthesia. Due to the specificity of the knee-chest position in a lumbar discectomy, many complications during anesthesia and surgery are possible. Therefore an effective and balanced intraoperative neuromuscular block is needed.\n\nStudies so far have not included a comparison on muscle strength and quality of patient recovery of the effect of continuous infusion and bolus doses of rocuronium during anesthesia for lumbar discectomy.\n\nThe hypothesis of this research was that the continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.\n\nThe aim was to compare the influence of the continuous infusion and bolus doses of rocuronium on patient recovery. Therefore the investigators assessed how continuous infusion and bolus doses of rocuronium affect the recovery of muscle strength as measured by a hand-grip dynamometer. The quality of patient recovery was assessed by standardised questionnaire (Qor-40 - Quality of recovery questionnaire).\n\nThe aim was also to evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA ( American Society of Anesthesiologists) grading status I-III\n* scheduled for lumbal discectomy under general anesthesia\n* signed informed consent for participating in the research\n\nExclusion Criteria:\n\n* neuromuscular disease\n* poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease\n* allergic reaction to any of the medications in protocol\n* pregnancy\n* refusal to participate in the research'}, 'identificationModule': {'nctId': 'NCT04236050', 'briefTitle': 'Continuous Infusion and Bolus Doses of Rocuronium During Lumbal Discectomy, Muscle Strength and Patient Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Hospital Centre Zagreb'}, 'officialTitle': 'Comparison of the Effect of Continuous Infusion and Bolus Doses of Rocuronium During Anesthesia for Lumbal Discectomy on Muscle Strength and Quality of Patient Recovery', 'orgStudyIdInfo': {'id': '021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rocuronium is administered via continuous infusion', 'description': '40 patients. General anesthesia is maintained with propofol and remifentanil, with standard anesthetic monitoring, bispectral index (BIS) and train-of-four(TOF). In experimental group, rocuronium was administered via continuous infusion so that theTOF ratio was 5%. Hand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.\n\nThe quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery', 'interventionNames': ['Drug: Rocuronium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rocuronium is administered in bolus doses', 'description': '40 patients. General anesthesia was maintained with propofol and remifentanil, with standard anesthetic monitoring, BIS and TOF. In this group, rocuronium was administered in separate bolus doses with the TOF ratio of 5%.\n\nHand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.\n\nThe quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery', 'interventionNames': ['Drug: Rocuronium']}], 'interventions': [{'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['general anesthesia'], 'description': 'Rocuronium administered in continuous infusion or multiple bolus doses', 'armGroupLabels': ['rocuronium is administered in bolus doses', 'rocuronium is administered via continuous infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'UHCZagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Hospital Centre Zagreb', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Martina Miklic Bublic, MD, PhD', 'investigatorAffiliation': 'Clinical Hospital Centre Zagreb'}}}}