An interventional study of placebo and Ringers Lactate in Diuresis, Bladder Retention Volume and Hypotension, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by Rijnstate Hospital · Not applicable and Interventional
The purpose of this study is to assess the influence of different fluid infusions on the quantity of bladder retention after spinal anesthesia. This study should determine if this increase in bladder retention is significant and relevant.
Background of the study:
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
Objective of the study:
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.
Study population:
ASA 1-2 patients who present for spinal anesthesia for minor surgery on the lower extremitiy. Age 18-60 years.
Intervention (if applicable):
Prespinal administration of intravenous Ringers' Lactate 14 ml/kg or HES 6% 7 ml/kg.
Primary study parameters/outcome of the study:
Primary outcome is total urinary volume during spinal induced detrusor blockade, and number of subjects that have a bladdder volume over 500ml.
Secundary study parameters/outcome of the study (if applicable):
Secondary outcome parameters:
Periods of hypertension, and total dose of vasopressor en extra fluid administration.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Except for extra bladderscan and block height measurements, all actions are part of routine anesthesiologic care.
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235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.
This study's enrollment of 144 is above the median of 95 across 185 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No preload
Other: placebo
Preload with cristalloid infusion
Drug: Ringers Lactate
Preload with collid infusion
Drug: HaemoHES 6%
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Rijnstate Hospital