Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-08 @ 7:52 AM
Study NCT ID:
NCT05549895
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2022-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-09-18', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total amount of fluids', 'timeFrame': 'intraoperative', 'description': 'Total amount of fluids needed to maintain mean blood pressure more than 65 mmHg'}, {'measure': 'Total amount of vasoactive drugs', 'timeFrame': 'Intraoperative', 'description': 'Total amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Intraoperative and up to 1hour postoperative', 'description': 'systolic and diastolic blood pressure and mean arterial blood pressure.'}, {'measure': 'Post-operative VAS score of pain assessment.', 'timeFrame': 'Up to one hour postoperative', 'description': 'Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).'}, {'measure': 'Post-operative shivering.', 'timeFrame': 'Up to 6 hours postoperatively.', 'description': 'shivering of the patient'}, {'measure': 'Post-operative nausea and vomiting.', 'timeFrame': 'Up to 6 hours postoperatively.', 'description': 'The presence of nausea or vomiting 6 hours post operatively'}, {'measure': 'Post dural puncture headache.', 'timeFrame': 'Up to 2 days postoperative', 'description': 'headache during 2 days postoperative and detection of severity and response to treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexamethasone', 'Urologic Endoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'Correction of Post-spinal anesthesia hypotension by fluids pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering.\n\nIn this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.', 'detailedDescription': 'Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgery. Spinal anesthesia avoids the risks of general anesthesia such as aspiration of gastric contents and difficulty with airway management.\n\nPost-spinal anesthesia hypotension in elderly patients is challenging. Correction of Post-spinal anesthesia hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance.\n\nMany advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering. Avoidance of complications of opioids is a great issue as, postoperative nausea, vomiting, respiratory depression, urinary retention, prolonged hospital stay and immunosuppression.\n\nIn this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\> 60 years old\n* Gender: Males and females\n* ASA grade I - II - III\n* Patients undergoing elective endoscopic urological procedures.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Suspected massive bleeding.\n* Transition to open abdominal surgery'}, 'identificationModule': {'nctId': 'NCT05549895', 'briefTitle': 'Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery', 'orgStudyIdInfo': {'id': 'Intrathecal Dexamethasone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug arm', 'description': '45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally .', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Bupivacaine Hydrochloride']}, {'type': 'OTHER', 'label': 'control arm', 'description': '45 patients will receive only bupivacaine intrathecally as a control group.', 'interventionNames': ['Drug: Bupivacaine Hydrochloride']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': '8 mg intrathecally', 'armGroupLabels': ['Drug arm']}, {'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'description': '0.5 % intrathecally', 'armGroupLabels': ['Drug arm', 'control arm']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecture', 'investigatorFullName': 'Dalia Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}