Influence of Spinal or Intravenous Dexmedetomidine on Spinal Anesthesia With Chloroprocaine and Bladder Function in Day-case Surgery. A Double Blind Randomized Study.

NCT02282319 Phase 4 COMPLETED

The primary objective of this double blind randomized study is to determine the effect of dexmedetomidine on onset and duration of the sensory and motor block and on the influence on bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that sensory block will significantly be prolonged by dexmedetomidine administered by both the spinal and the intravenous route. The investigators do not expect a significant difference in motor block duration between intravenous or spinal administration. Secondary outcomes are micturition problems, duration of analgesia and the occurrence of side effects such as sedation and hypotension.

Details

Lead sponsor	University Hospital, Antwerp
Phase	Phase 4
Status	COMPLETED
Enrolment	150
Start date	2014-10
Completion	2020-12

Conditions

• Surgery Ambulatory

Interventions

• spinal dexmedetomidine 0.5 mcg
• spinal chloroprocaine 40 mg
• IV dexmedetomidine 0.5 mcg/kg

Primary outcomes

• sensory block regression L2 dermatome (minutes) (Time from injection until First time registration of loss of cold sensation) — up to 360 minutes
  Time from injection until First time registration of loss of cold sensation at the L2 dermatome during block regression. Loss of cold sensation will be regularly assessed from spinal injection until total regression of the sensory block
• Motor block regression (minutes) (time from injection until achievement of active knee movement) — up to 240 minutes
  time from injection until achievement of active knee movement during block regression. Motor block will be assessed at regular intervals from spinal injection untill total regression of the motor block

Countries

Belgium