Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine on Hemodynamic Parameters in Patients Undergoing Transurethral Resection of the Prostate

SAbbas

Patients will be enrolled in one of the two groups using a computer-generated random number table: Group I will receive 1.5 ml of 0.5% hyperbaric bupivacaine (7.5 mg). Group II will receive 1.2 mL of 0.5% hyperbaric bupivacaine (6 mg) along with 0.3 mL (3 μg )of dexmedetomidine (total 1.5 mL).

2021-07-20

2022-02-18

2022-02-18

Completed

Early phase I

108

Inclusion Criteria: * ASA I to ASA II * Age 50 to 80 years old * Height between 155cm and 175 cm Exclusion Criteria: * History of spine surgery or the presence of an infectious focus on the back * Patient's refusal to undergo a spinal anaesthesia * Hypersensitivity to bupivacaine or dexmedetomidine * Patients taking drugs of abuse or narcotic analgesics * Diabetic neuropathy * History of bleeding disorders * Oral/intravenous anticoagulant therapy * History of arrhythmias or labile hypertension * Unco-operative patients * Hearing defect * ASA III and IV * Central or peripheral nervous system disorders * Severe hypovolemia

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group BUPPURE will receive 1.5 ml of hyperbaric 0.5% bupivacaine (1.5 ml/7.5 mg) whereas the BUPIDEX group will receive Dexmedetomidine 3 micrograms (0.3mL)with hyperbaric 0.5% bupivacaine (1.2 ml/6 mg) to be given to one group.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 108, 'type': 'ACTUAL'}}

2023-10-31