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Clinical trial

A Randomized Comparative Evaluation Of The Effects Of Dexmedetomidine As An Adjuvant With Bupivacaine In Supraclavicular Block In Chronic Renal Failure Patients Undergoing Basilic Vein Transposition Surgery

ID
Name
SIUT-ERC-2020/PA-257
Description
End-stage renal disease (ESRD) patients are coming for Brachial vein transposition surgery. Patients were randomly allocated using sealed opaque envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml). Supraclavicular block under ultrasound and nerve stimulator guidance was performed.
Trial arms
Trial start
2021-02-15
Estimated PCD
2021-04-30
Trial end
2021-04-30
Status
Completed
Phase
Early phase I
Treatment
DEXmedetomidine
28 mL of Bupivacain 0.25% was mixed with Dexmedetomidine 1 microgram/kg body weight mixed in 2 mL = total volume 30 mL
Arms:
Bupivacaine0.25%+DEX
Other names:
DEX
saline
28 mL of Bupivacain 0.25% was mixed with 2 mL of Normal saline = total volume 30 mL
Arms:
BUPIvacaine 0.25%
Size
108
Primary endpoint
Pain score
0-4 hours
Heart rate
0-4 hours
Mean blood pressure
0-4 hours
Eligibility criteria
Inclusion Criteria: * Chronic renal failure patients who will undergo elective basilic vein transposition surgery * Either gender * ASA III * Age 18-65 years. Exclusion Criteria: * Mentally challenged * Pregnancy. * Hypersensitivity to bupivacaine or dexmedetomidine * Seizures * Neck swelling (hematoma, lipoma, tumor, thyroid) * Neuromuscular dystrophy * Bleeding disorders
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 108, 'type': 'ACTUAL'}}
Updated at
2023-08-14

1 organization

1 product

1 indication

Organization
Sindh Institute of Urology and Transplantation
Product
DEXmedetomidine
Indication
Pain