Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-24 @ 4:24 PM
Study NCT ID:
NCT02146859
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2014-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictor of Residual Neuromuscular Blockade in Recovery Room After General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-24', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual neuromuscular blockade after surgery', 'timeFrame': '1 hour', 'description': 'residual neuromuscular blockade after surgery measure by train of four of nervestimulator'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['residual neuromuscular blockade'], 'conditions': ['Residual Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'Background When general anesthesia was performed, neuromuscular blocking agents (NMBAs) are frequently used for facilitate tracheal intubation and keep patient still and relax during surgery. Unfortunately, residual neuromuscular blockade are important complication.\n\nThere are many factors that affect neuromuscular blockade and may prolong effect of NMBAs which we already know about that such as body temperature, drugs, some kind of diseases. However there are no recent studies that mention about other factors. The purpose of this study is to find out other factors that affect NMBAs effect to improve patient safety.\n\nMethods The study is a prospective, non-randomized, blinded, observational study.\n\n222 patients will be included in this study and will be performed general anesthesia. Anesthetic technique and agent which are used depend on regular staff. Information of patient will be collected are age, sex, weight, height, ASA classification, anesthetic technique, anesthetic and surgical time, amount of inhalation agent, amount of NMBAs, amount of opioids and reversal agents.\n\nAfter anesthesia finish, patient will be brought to recovery room and Train Of Four watch® will be placed and record Train Of Four ratio by this research staff. Train Of Four ratio \\< 0.9 will be defined as there is residual neuromuscular blockade in this patient.\n\nAll patients will be divided into 2 groups: residual blockade group(patient who have train of four \\<0.9 after surgery) and no residual blockade group(patient who have train of four \\>0.9). All factor of each group will be compared between. Statistical will be analyzed to find significant factor which affect neuromuscular blockade.', 'detailedDescription': 'study about residual neuromuscular blockade'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient who are schedule for general anesthesia and use neuromuscular blocking agents (NMBAs)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- age ≥ 18 years\n* American society of anesthesiologist class I-III\n* patient who are schedule for intraabdominal surgery, orthopedic surgery and gynecologic surgery under general anesthesia and use neuromuscular blocking agents (NMBAs)\n\nExclusion Criteria:\n\n* \\- patients who have myasthenia gravis, myotonia, muscular dystrophy, upper motor neuron lesion\n* patients who have drug which influence neuromuscular action such as oral muscle relaxant, anticonvulsants, magnesium sulfate\n* Body temperature \\>37.8 or \\< 36 degree Celsius before operation'}, 'identificationModule': {'nctId': 'NCT02146859', 'briefTitle': 'Predictor of Residual Neuromuscular Blockade in Recovery Room After General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Predictor of Residual Neuromuscular Blockade in Recovery Room After General Anesthesia', 'orgStudyIdInfo': {'id': 'Si123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'general anesthesia', 'description': 'Patient having general anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of medicine Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Chaowanan Khamtuikrua', 'investigatorAffiliation': 'Mahidol University'}}}}