Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-13 @ 4:27 PM
Study NCT ID:
NCT02365857
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2015-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-30', 'studyFirstSubmitDate': '2015-02-04', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time to two sensory block segment regression.', 'timeFrame': '70 min', 'description': 'Define the start of regression of the level of sensory block'}], 'secondaryOutcomes': [{'measure': 'The peak sensory level of the block.', 'timeFrame': '10 min', 'description': 'By Pin Prick testing.'}, {'measure': 'Time from intrathecal injection to peak sensory block level.', 'timeFrame': '10 min', 'description': 'Define the speed of onset of the block.'}, {'measure': 'Time to S1 level sensory regression.', 'timeFrame': '70 min', 'description': 'Define duration of the block.'}, {'measure': 'Degree of motor block.', 'timeFrame': '24 h', 'description': 'By Modified Bromage Score.'}, {'measure': 'Intraoperative hemodynamic variables.', 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}, {'measure': 'The total dose of ephedrine/atropine required to maintain hemodynamic stability.', 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}, {'measure': "The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range", 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}, {'measure': 'Oxygen saturation (the need for O2 supplementation)', 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}, {'measure': 'Intraoperative analgesic supplementation', 'timeFrame': '70 min', 'description': 'Define quality of the block'}, {'measure': 'Time to first postoperative rescue analgesic request', 'timeFrame': '24 h', 'description': 'Define duration of analgesia by the block'}, {'measure': 'Postoperative pain scores for 24 hours', 'timeFrame': '24 h', 'description': 'Define duration of analgesia by the block'}, {'measure': 'Frequency of administration of postoperative analgesics', 'timeFrame': '24 h', 'description': 'Define duration of analgesia by the block'}, {'measure': 'Intraoperative sedation scores', 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}, {'measure': 'Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)', 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}, {'measure': 'New born Apgar Score', 'timeFrame': '5 min', 'description': 'Detect any effects on the new born at different dose levels'}, {'measure': 'Duration of motor block.', 'timeFrame': '24 h', 'description': 'By Modified Bromage Score.'}, {'measure': 'Early postoperative hemodynamic variables.', 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}, {'measure': 'Total dose of postoperative analgesics', 'timeFrame': '24 h', 'description': 'Define duration of analgesia by the block'}, {'measure': 'Postoperative sedation scores', 'timeFrame': '24 h', 'description': 'Detect frequency of side effects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spinal anesthesia', 'caesarian section', 'Dexmedetomidine'], 'conditions': ['Anesthesia, Spinal']}, 'descriptionModule': {'briefSummary': 'A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and side effect profile of different dose levels of Dexmedetomidine added to subarachnoid bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal anesthesia. The investigators ultimate goal is to find out the least effective dose which will be associated with minimal or no side effects. The primary outcome will be the time to two sensory block segment regression.', 'detailedDescription': 'Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal local anesthetics, the regression of sensory and motor blocks increased dose-dependently. Further, a recent meta-analysis including seven randomized controlled studies reported an increase in the duration of analgesia and reduced morphine requirement after the concomitant subarachnoid administration of clonidine.\n\nAnimal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and 14 days after the peri-neural administration of Dexmedetomidine. Several clinical studies confirmed the analgesic potentials and safe neurological outcome of neuraxially administered Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied before in the obstetric patient population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-term pregnant women.\n* Elective cesarean section using spinal anesthesia.\n* Singleton gestation.\n* American Society of Anesthesiologists (ASA) physical status classes I and II.\n\nExclusion Criteria:\n\n* Preterm pregnancy (\\<37 wks gestation).\n* Multiple gestation.\n* Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medication.\n* Conditions that preclude spinal anesthesia.\n* Failed spinal block and conversion to general anesthesia.\n* A history of established chronic pain.\n* Drug addiction.\n* A psychiatric disorder.\n* Inability to communicate effectively.\n* Asthma and allergy to non-steroidal anti-inflammatory drugs.'}, 'identificationModule': {'nctId': 'NCT02365857', 'briefTitle': 'Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effects of Intrathecal Dexmedetomidine on the Perioperative Clinical Profile of Bupivacaine-induced Spinal Anesthesia for Cesarean Section', 'orgStudyIdInfo': {'id': 'thecaldex'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DEX-5', 'description': 'Dexmedetomidine \\& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 5 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.', 'interventionNames': ['Drug: Dexmedetomidine & Bupivacaine.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEX-10', 'description': 'Dexmedetomidine \\& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 10 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.', 'interventionNames': ['Drug: Dexmedetomidine & Bupivacaine.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEX-15', 'description': 'Dexmedetomidine \\& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 15 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.', 'interventionNames': ['Drug: Dexmedetomidine & Bupivacaine.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Bupivacaine Only. Patients will receive intrathecal 12.5 mg isobaric bupivacaine only using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.', 'interventionNames': ['Drug: Bupivacaine Only.']}], 'interventions': [{'name': 'Dexmedetomidine & Bupivacaine.', 'type': 'DRUG', 'description': 'Intrathecal injection of Dexmedetomidine \\& Bupivacaine.', 'armGroupLabels': ['DEX-10', 'DEX-15', 'DEX-5']}, {'name': 'Bupivacaine Only.', 'type': 'DRUG', 'description': 'Intrathecal injection of Bupivacaine only.', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Abdulatif M.', 'investigatorFullName': 'Professor Mohamed Abdulatif Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}