Effect of Preload on Bladder Retention Volume During Spinal Anesthesia

The Effect of Intravascular Preload on Bladder Retention Volume During Spinal Anesthesia Induced Detrusor Blockade

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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Diuresis; Bladder Retention Volume
• Intervention / Treatment: Other: placebo; Drug: Ringers Lactate; 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.

Ga naar boven

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Zevenaar, Gelderland, Netherlands
      • Ziekenhuis Zevenaar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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%

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Marco Peters, MD, Nijmegen University Anesthesiology Department (resident); Principal Investigator: Ed Kamphuis, Md, PhD, Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: October 26, 2007
• First Submitted That Met QC Criteria: October 26, 2007
• First Posted (Estimate): October 29, 2007

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: spinal anesthesia; preload; diuresis; bladder retention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Urination Disorders; Hypotension; Urinary Retention
• Other Study ID Numbers: LTC-420-071206