Objective: to compare the quantitative effects of Ringer Lactate and HES 6% on diuresis during spinal anesthesia-induced detrusor blockade as well as prevention of hypotension and vasopressor use.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
perioperatieve anesthesiologische zorg
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is total urinary volume during spinal induced detrusor
blockade, and number of subjects that have a bladdder volume over 500ml.
Secondary outcome
Secondary outcome parameters:
Periods of hypertension, and total dose of vasopressor en extra fluid
administration.
Background summary
Spinal anesthesia , through interruption of spinal nerve conduction, causes
intense blockade of sensation, motor function as well as (para)sympathetic
function. Loss of sympathetic tone causes vasodilation which may lead to
arterial hypotension and bradycardia. To avoid these effects, in anesthetic
practice, usually intravenouspreload is administered as cristalloids or
colloids. The form and dosage of these plasma expanders will influence diuresis
during spinal anesthesia-induced detrusor blockade. Excess diuresis may cause
bladder distension and neccecitates bladder catheterization
Study objective
Objective: to compare the quantitative effects of Ringer Lactate and HES 6% on
diuresis during spinal anesthesia-induced detrusor blockade as well as
prevention of hypotension and vasopressor use.
Study design
Before spinal anesthesia is performed, patients are randomized into one of the
3 study groups (no preload, preload with Ringers' Lactate 14 ml/kg, preload
with HES 6% 7 ml/kg). Spinal anesthesia is administerd with lidocaine 2% 70mg.
Hypotension is treated with vasopressors, atropine or additional intravenous
fluid. Bladder scans will be performed on the recovery unit and day-case unit.
Total urinary volume is measured until sensory function at dermatome S2/3 is
restored and spontanous voiding is possible.
Intervention
Prespinal administration of intravenous Ringers' Lactate 14 ml/kg or HES 6% 7
ml/kg.
Study burden and risks
Except for extra bladderscan and block height measurements, all actions are
part of routine anesthesiologic care.
Wagnerlaan 55
Arnhem
Nederland
Wagnerlaan 55
Arnhem
Nederland
Listed location countries
Age
Inclusion criteria
patients planned for short, minor surgery of lower extremity under spinal anesthesia.
Exclusion criteria
any urologic, neurologic, cardiac, vascular disease.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2007-000702-71-NL |
CCMO | NL11881.091.07 |