Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT06679569
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Neuromuscular Blockade on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ANIm (Analgesia Nociception Index) Value', 'timeFrame': '30 minutes after arrival in the recovery room'}], 'secondaryOutcomes': [{'measure': 'FLACC Pain Scale', 'timeFrame': '30 minutes after arrival in the recovery room'}, {'measure': 'Pediatric Anesthesia Emergence Delirium Scale', 'timeFrame': '30 minutes after arrival in the recovery room'}, {'measure': 'Time to Extubation', 'timeFrame': 'From end of surgery to extubation (in minutes, assessed up to 1 hour)'}, {'measure': 'Recovery Room Length of Stay', 'timeFrame': 'Duration of stay in the recovery room (in minutes, assessed up to 2 hours)'}, {'measure': 'Remifentanil Consumption During Anesthesia', 'timeFrame': 'During surgery ( assessed up to 5 hours)', 'description': 'mcg/kg/min'}, {'measure': 'Change in Pain Score (FLACC Pain Scale)', 'timeFrame': 'Every 6 hours up to 24 hours post-surgery'}, {'measure': 'Maximum Pain Score (FLACC Pain Scale) within 24 Hours', 'timeFrame': 'Within 24 hours post-surgery'}, {'measure': 'Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight', 'timeFrame': 'Within 24 hours post-surgery'}, {'measure': 'Peak Intraabdominal Pressure During Surgery', 'timeFrame': 'During surgery (assessed up to 5 hours)'}, {'measure': 'Peak Inspiratory Pressure During Surgery', 'timeFrame': 'During surgery (assessed up to 5 hours)'}, {'measure': 'Leiden Surgical Rating Scale', 'timeFrame': 'During surgery (assessed up to 5 hours)'}, {'measure': 'Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement)', 'timeFrame': 'During recovery room stay (assessed up to 2 hours)'}, {'measure': 'Any complications Occurring Before Discharge', 'timeFrame': 'Up to discharge (assessed up to 1 month)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pediatric patients aged over 2 months to under 7 years scheduled for laparoscopic surgery under general anesthesia.\n* American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery.\n* Patients with chronic pain or currently taking analgesics for chronic pain.\n* Known hypersensitivity to general anesthetic agents or analgesics.\n* Patients with underlying cardiovascular disease.\n* Patients with neuromuscular disorders.\n* Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study."}, 'identificationModule': {'nctId': 'NCT06679569', 'briefTitle': 'Deep Neuromuscular Blockade on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Deep Neuromuscular Blockade on Postoperative Pain in Pediatric Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2410-015-1575'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'moderate neuromuscular blockade', 'interventionNames': ['Drug: rocuronium 0.2 mg/kg/hr continuous infusion']}, {'type': 'EXPERIMENTAL', 'label': 'deep neuromuscular blockade', 'interventionNames': ['Drug: rocuronium 0.6 mg/kg/hr continuous infusion']}], 'interventions': [{'name': 'rocuronium 0.2 mg/kg/hr continuous infusion', 'type': 'DRUG', 'description': 'To maintain Train-of-four count 1 to 3 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.2 mg/kg/hr to achieve and sustain moderate neuromuscular blockade.', 'armGroupLabels': ['moderate neuromuscular blockade']}, {'name': 'rocuronium 0.6 mg/kg/hr continuous infusion', 'type': 'DRUG', 'description': 'To maintain Train-of-four count 0 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.6 mg/kg/hr to achieve and sustain deep neuromuscular blockade.', 'armGroupLabels': ['deep neuromuscular blockade']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Clinical Assistant', 'role': 'CONTACT', 'email': 'snuh.pedane@gmail.com', 'phone': '82-2-2072-3664'}], 'facility': 'SNUCH', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Clinical Assistant', 'role': 'CONTACT', 'email': 'snuh.pedane@gmail.com', 'phone': '82-2-2072-3664'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji-Hyun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}