Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01824758
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2013-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Esmolol on Pain Due to Rocuronium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C036604', 'term': 'esmolol'}, {'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2013-03-01', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To assess patient satisfaction', 'timeFrame': '1 Month'}], 'primaryOutcomes': [{'measure': 'The injection pain due to rocuronium', 'timeFrame': '1 month', 'description': 'Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).'}], 'secondaryOutcomes': [{'measure': 'Score on pain due to injection of rocuronium', 'timeFrame': '1 month', 'description': 'Withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['esmolol, injection pain, lidocaine, rocuronium'], 'conditions': ['Injection Site Irritation']}, 'descriptionModule': {'briefSummary': '90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0.5 mg/kg rocuronium.', 'detailedDescription': 'Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I and II patients\n* Undergoing general anesthesia for elective surgery\n\nExclusion Criteria:\n\n* Known allergy to esmolol or lidocaine\n* Chronic pain\n* Pregnancy\n* Withdrawal of consent by the patient'}, 'identificationModule': {'nctId': 'NCT01824758', 'briefTitle': 'Effect of Esmolol on Pain Due to Rocuronium', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Diskapi Training and Research Hospital'}, 'officialTitle': 'The Effect of Esmolol on Pain Due to Rocuronium Injection Pain', 'orgStudyIdInfo': {'id': 'ESM 0538'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brevibloc (esmolol)', 'description': 'Group E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL)', 'interventionNames': ['Drug: Esmolol', 'Drug: rocuronium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aritmal (Lidocaine)', 'description': 'Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)', 'interventionNames': ['Drug: Lidocaine', 'Drug: rocuronium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (NaCl 0.9%, 5 ml)', 'description': 'Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)', 'interventionNames': ['Drug: rocuronium', 'Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Aritmal, Jetmonal'], 'description': 'Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).', 'armGroupLabels': ['Aritmal (Lidocaine)']}, {'name': 'Esmolol', 'type': 'DRUG', 'otherNames': ['brevibloc'], 'description': 'Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)', 'armGroupLabels': ['brevibloc (esmolol)']}, {'name': 'rocuronium', 'type': 'DRUG', 'description': '0.05 mg/kg rocuronium', 'armGroupLabels': ['Aritmal (Lidocaine)', 'Placebo (NaCl 0.9%, 5 ml)', 'brevibloc (esmolol)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)', 'armGroupLabels': ['Placebo (NaCl 0.9%, 5 ml)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Altindag', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Teaching and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Fakelma 05327079113', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diskapi Teaching and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Diskapi Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Fatma Kavak Akelma', 'investigatorAffiliation': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital"}}}}