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Intrathecal Dexmedetomidine as Adjuvant to Bupivacaine in TURP
NCT05993975Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2021
- Primary completion
- Feb 2022
- Countries
- 1
- Sponsor
- Sindh Institute of Urology and Transplantation
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- benign prostatic hyperplasia (BPH)
01
Overview
Phase 4, randomised, double-blind trial of dexmedetomidine in benign prostatic hyperplasia (BPH) (2 arms), sponsored by Sindh Institute of Urology and Transplantation. Primary endpoints: Height of sensory block, Motor block and 3 more. Started Jul 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
BUPIPURE
1.5 ml of 0.5% hyperbaric bupivacaine (7.5 mg)
BUPI-DEX
1.2 mL of 0.5% hyperbaric bupivacaine (6 mg) + 0.3 mL (3 μg) dexmedetomidine
03
Who it enrols
Male patients aged 50-80 years, ASA I-II, undergoing TURP, with height 155-175 cm. Excludes patients with spine surgery history, infection, bleeding disorders, diabetic neuropathy, or severe cardiovascular/CNS conditions.
04
Endpoints
Primary
Height of sensory block
Motor block
Time for 2 segment regression of sensory block
Heart rate
Mean Blood pressure
Secondary
Shivering
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