Topic 01 / 47
Link to this entryIntrathecal dexmedetomidine versus fentanyl as an adjuvant to hyperbaric bupivacaine in elective lower limb surgery: a randomised double-blind comparison
- Primary outcome
- Time to two-segment regression of sensory block, in minutes
- Collection time
- 10 to 12 months of enrolment
- Sample, as a planning figure
- roughly 35 to 45 per group, subject to a proper calculation
What your unit must already have
- A regular elective orthopaedic or lower limb list done under subarachnoid block
- Pharmacy supply of preservative-free adjuvant and a written undertaking on its use
- A second anaesthetist who records block regression without knowing the allocation
What derails it
Preservative-free dexmedetomidine is not stocked by every hospital pharmacy and its intrathecal use is off-label, so the ethics committee usually asks for a pharmacy undertaking and a justification from published practice before it clears the protocol; settle that in writing before the synopsis goes in, not after.