Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-04 @ 2:04 AM
Study NCT ID:
NCT03344393
Status:
UNKNOWN
Last Update Posted:
2017-11-17
First Post:
2017-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-13', 'studyFirstSubmitDate': '2017-11-09', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '2 days postoperative', 'description': 'IV PCA'}], 'secondaryOutcomes': [{'measure': 'cortisol level', 'timeFrame': '2 days postoperative', 'description': 'salivary'}, {'measure': 'alpha amylase level', 'timeFrame': '2 days postoperative', 'description': 'salivary'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia']}, 'referencesModule': {'references': [{'pmid': '26840358', 'type': 'BACKGROUND', 'citation': 'Arikan M, Aslan B, Arikan O, Horasanli E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010.'}]}, 'descriptionModule': {'briefSummary': '.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.', 'detailedDescription': 'I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.\n\nII- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'above 18', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\- Patient's status ASA status-I and II.\n* Patients age above 18 years old.\n* Patients scheduled for intestinal surgery.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Patients with known allergy to ketamine or morphine.\n* Patients with significant hepatic dysfunction.\n* Patients with severe renal disease.\n* Significant Heart disease.\n* Patients with chronic pain.\n* Regular use analgesics, antidepressants or opioids in last 2 months.\n* Any known convulsive disorder.\n* Morbid obesity (BMI\\>35).\n* Patients with autoimmune disease\n* Patients on corticosteroid therapy\n* Pregnancy.\n* Breast feeding.\n* Woman under hormonal treatment.\n* Oral disease."}, 'identificationModule': {'nctId': 'NCT03344393', 'briefTitle': 'Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery and Its Effect on Salivary Cortisol and Alpha Amylase Levels', 'orgStudyIdInfo': {'id': '17200147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine hydrochloride', 'description': 'intravenous ketamine infusion in the intraoperative period', 'interventionNames': ['Drug: Ketamine Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal saline', 'description': 'intravenous normal saline infusion in the intraoperative period', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Ketamine Hydrochloride', 'type': 'DRUG', 'otherNames': ['ketalar'], 'description': 'intravenous ketamine infusion intraoperatively', 'armGroupLabels': ['ketamine hydrochloride']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Sodium chloride solution'], 'description': 'intravenous normal saline infusion intraoperatively', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mohamed aly, MD', 'role': 'CONTACT', 'email': 'galalm1967@yahoo.com', 'phone': '00201062011126'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mohamed galal aly', 'investigatorAffiliation': 'Assiut University'}}}}