Effect of Preload on Bladder Retention Volume During Spinal Anesthesia
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diuresis Bladder Retention Volume Hypotension |
Other: placebo Drug: Ringers Lactate Drug: HaemoHES 6% |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | The Effect of Intravascular Preload on Bladder Retention Volume During Spinal Anesthesia Induced Detrusor Blockade |
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
No preload
|
Other: placebo |
|
Active Comparator: 2
Preload with cristalloid infusion
|
Drug: Ringers Lactate |
|
Active Comparator: 3
Preload with collid infusion
|
Drug: HaemoHES 6% |
Detailed Description:
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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Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA1-2
- undergoing minor procedure under spinal anesthesia
Exclusion Criteria:
- ASA3-4
- History or signs of heart failure / coronary artery disease.
- Bladder / urinary disease
- Neurologic disease that may affect bladder function
Contacts and Locations| Contact: Marco Peters, MD | 0031464124 | m.peters@anes.umcn.nl |
| Contact: Ed Kamphuis, PhD, MD | ekamphuis@alysis.nl |
| Netherlands | |
| Ziekenhuis Zevenaar | Recruiting |
| Zevenaar, Gelderland, Netherlands | |
| Principal Investigator: | Marco Peters, MD | Nijmegen University Anesthesiology Department (resident) |
| Principal Investigator: | Ed Kamphuis, Md, PhD | Rijnstate Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00550186 History of Changes |
| Other Study ID Numbers: | LTC-420-071206 |
| Study First Received: | October 26, 2007 |
| Last Updated: | October 26, 2007 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate |
Keywords provided by Rijnstate Hospital:
|
spinal anesthesia preload diuresis bladder retention |
Additional relevant MeSH terms:
|
Hypotension Urinary Retention Vascular Diseases Cardiovascular Diseases Urination Disorders Urologic Diseases |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013