Effect of Preload on Bladder Retention Volume During Spinal Anesthesia

NCT ID: NCT00550186

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31

Brief Summary

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.

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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Conditions

Diuresis; Bladder Retention Volume; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

2

Preload with cristalloid infusion

Group Type: ACTIVE_COMPARATOR

Ringers Lactate

Intervention Type: DRUG

3

Preload with collid infusion

Group Type: ACTIVE_COMPARATOR

HaemoHES 6%

Intervention Type: DRUG

1

No preload

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

placebo

Intervention Type: OTHER

Ringers Lactate

Intervention Type: DRUG

HaemoHES 6%

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Marco Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Nijmegen University Anesthesiology Department (resident)

Ed Kamphuis, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Ziekenhuis Zevenaar

Zevenaar, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

LTC-420-071206

Identifier Type: -

Identifier Source: org_study_id