Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-11 @ 2:59 PM
Study NCT ID:
NCT01661803
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2012-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-09', 'studyFirstSubmitDate': '2012-08-04', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bupivacaine', 'clonidine', 'pediatric spinal', 'efficacy', 'duration', 'quality', 'side effects', 'intrathecal bupivacaine alone', 'bupivacaine plus clonidine'], 'conditions': ['Pediatric Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects.', 'detailedDescription': 'In our Randomized controlled, double blind study involving 30 subjects in two groups; the investigators compared the safety, efficacy and quality of using intrathecal hyperbaric bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients undergoing surgeries below T8 dermatome.\n\nAmerican Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.\n\nGroup B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg and 1µg/kg preservative free clonidine intrathecally.\n\nThe patients studied across the group did not vary much with respect to age, weight and sex distribution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'prospective,randomized,double blind study cariied in 60 ASA grade 1 pediatric patients undergoing surgeries below T8 dermatome upto two hours duration.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA grade-1 physical status.\n2. weight 5-35kg\n3. age-3 to 10 yrs\n\nExclusion Criteria:\n\n1. patients with known sensitivity to drugs to be used.\n2. gross spinal deformity\n3. patients in whom regional anesthesia is contraindicated.\n4. patients with peripheral neuropathy.\n5. patient with hemodynamic instability.'}, 'identificationModule': {'nctId': 'NCT01661803', 'briefTitle': 'Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'ACPM Medical College'}, 'officialTitle': 'Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation', 'orgStudyIdInfo': {'id': 'acpm anesthesia.dhule.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group-A and group-B', 'description': 'Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \\>15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \\>15 with 1 mcg/kg preservative free clonidine).'}, {'label': 'group-A and group--B', 'description': 'Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \\>15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for \\>15 with 1 mcg/kg preservative free clonidine).'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ACPM Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident,anesthesia department,a.c.p.m.medical college,dhule,maharashtra,india', 'investigatorFullName': 'DR.NAGESH JAMBURE', 'investigatorAffiliation': 'ACPM Medical College'}}}}