Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 10:30 PM
Study NCT ID:
NCT04582032
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118296', 'term': 'dexketoprofen trometamol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-04', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'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': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexketoprofen, pain, rocuronium'], 'conditions': ['Injection Site Irritation']}, 'descriptionModule': {'briefSummary': "Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.\n\n0;No movement response to injection\n\n1. Mild movement response to injection\n2. Hand withdrawal response to injection\n3. Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.\n\nQuestion 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?", 'detailedDescription': "Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below.\n\n0;No movement response to injection\n\n1. Mild movement response to injection\n2. Hand withdrawal response to injection\n3. Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.\n\nQuestion 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non allergic to dexketoprofen\n* 18-60 years old\n* American Society of Anesthesiologists(ASA) 1-2-3\n* 70-90 kg weigh\n\nExclusion Criteria:\n\n* patients with psychiatric and mental problems'}, 'identificationModule': {'nctId': 'NCT04582032', 'briefTitle': 'Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Effects of COX 1-2 Inhibitors on Prevention of Rocuronium Injection Pain: Controlled, Randomised, Double Blind Study', 'orgStudyIdInfo': {'id': 'roc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexketoprofen group,', 'description': 'IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in dexketoprofen group were administered intravenous dexketoprofen (50 mg/2ml) and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction', 'interventionNames': ['Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)']}, {'type': 'OTHER', 'label': 'Saline group', 'description': 'IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in control group were administered intravenous 2 ml of saline and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction', 'interventionNames': ['Drug: Saline (Isotonic Saline Solution 0.9% )']}], 'interventions': [{'name': 'Dexketoprofen (KETAVEL 50 mg/2 ml)', 'type': 'DRUG', 'description': 'intravenous dexketoprofen (KETAVEL 50 mg/2 ml)', 'armGroupLabels': ['Dexketoprofen group,']}, {'name': 'Saline (Isotonic Saline Solution 0.9% )', 'type': 'DRUG', 'description': 'intravenous 2 ml of saline', 'armGroupLabels': ['Saline group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Kecioren Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Mehmet sahap', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}