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Effect of Preload on Bladder Retention Volume During Spinal Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00550186
First Posted: October 29, 2007
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rijnstate Hospital
  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: Triple (Care Provider, Investigator, Outcomes Assessor)
Official Title: The Effect of Intravascular Preload on Bladder Retention Volume During Spinal Anesthesia Induced Detrusor Blockade

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Enrollment: 144
Study Start Date: October 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550186


Locations
Netherlands
Ziekenhuis Zevenaar
Zevenaar, Gelderland, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: Marco Peters, MD Nijmegen University Anesthesiology Department (resident)
Principal Investigator: Ed Kamphuis, Md, PhD Rijnstate Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00550186     History of Changes
Other Study ID Numbers: LTC-420-071206
First Submitted: October 26, 2007
First Posted: October 29, 2007
Last Update Posted: June 28, 2016
Last Verified: June 2016

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