Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000290099
Ethics application status
Approved
Date submitted
5/04/2010
Date registered
12/04/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the Effects of Fluid Preload (Crystalloid versus Colloid) Which Is Performed for Prevention of Spinal Anesthesia-induced Hypotension on Time to Reach Peak Sensory Block Level and Cerebrospinal Fluid Movement in Patients Scheduled to Undergo an Elective Transurethral Resection of a Bladder Tumor under Isobaric Spinal Anesthesia
Scientific title
Comparison of the Effects of Preanesthetic Administration of Crystalloid versus Colloid on Intrathecal Spread of Isobaric Spinal Anesthetics and Cerebrospinal Fluid Movement in Patients Scheduled to Undergo an Elective Transurethral Resection of a Bladder Tumor under Spinal Anesthesia
Secondary ID [1] 1580 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary bladder tumor
and healthy human volunteer study 257095 0
Condition category
Condition code
Anaesthesiology 257249 257249 0 0
Anaesthetics
Cancer 257261 257261 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinical study for isobaric spinal anesthesia:
Sixty-three patients (American Society of Anesthesiology (ASA) physical status I and II; aged 70 yr or younger; males and females) scheduled to undergo an elective transurethral resection of a bladder tumor under spinal anesthesia were enrolled in this study. The patients were allocated randomly into one of two groups using a stratified sealed envelope method; lactated Ringer's solution (crystalloid) group or electrolytes-containing hextend (colloid) group. Upon arrival at the waiting area of the operating room approximately 20 minutes prior to initiation of spinal anesthesia, an anesthesiologist who participated in neither isobaric spinal anesthesia nor in determining the sensory block level, intravenously administered either 15 mL/kg of lactated Ringer’s solution or 5 mL/kg of electrolytes-containing hextend (Hospira, Inc., Lake Forest, IL, USA) to the patients over a 10 to 15 min period and then removed the solution from the patient' intravenous route for group-blindness. Subsequently, the patients were transferred to the operating room. Routine monitoring by electrocardiogram (ECG), non-invasive arterial blood pressure, and pulse oximetry were performed and the baseline measurements were recorded. Another group-blinded anesthesiologist performed the spinal anesthesia with the patient in the right lateral decubitus position. In all patients, a midline approach was used at the mid-lumbar level (Tuffier’s line) with a 25-gauge Whitacre spinal needle (BD Whitacre needle, BD Medical System, NJ, USA). A 0.5% isobaric tetracaine solution was prepared by dissolving 20 mg of crystalline tetracaine hydrochloride (Pantocainesterile, Daehan Med Co, Seoul, Korea) into 4 ml of the cerebrospinal fluid (CSF) withdrawn through a Whitacre spinal needle. Tetracaine 12mg (2.4 mL of the dissolved solution) was administered slowly into the intrathecal space over a 30 s period. The patient was placed in the horizontal supine position for 5 min and then in the lithotomy position. The sensory block levels were determined by a midline pinprick at 5 min intervals for the first 30 min and then at 15 min intervals until 90 min after the intrathecal injection of 0.5% isobaric tetracaine. Routine monitoring was recorded every 5 minutes. Ephedrine 5 mg was injected if hypotension (defined as a > 30% decrease in the mean arterial blood pressure from baseline measurement) occurred, and 0.5 mg of atropine was injected in the case of bradycardia (heart rate < 50/min).

Volunteer study for Magnetic resonance (MR) imaging;
Twenty-three healthy male volunteers (age range, 21-26 years), who were free from neurological disease and spinal deformity with no history of medication, were enrolled in this study. All quantitative assessments of the CSF movement by cardiac gated, phase-contrast cine high resolution MR imaging were performed between 6:00 PM and 8:00 PM because the rate of CSF production in healthy adults is affected by the circadian rhythm. Each volunteer underwent two sequential MR imaging studies at 1 week intervals. The first MR imaging study involved intravenous administration of lactated Ringer's solution. The initial MR images were taken for the baseline MR images obtained from volunteer at baseline. Subsequently 15 mL/kg of lactated Ringer’s solution was intravenously administered over a 10 to 15 min period and MR images were taken 30 and 60 min after the baseline MR images had been taken. One week after the crystalloid study, the same volunteers underwent a colloid study receiving 5 mL/kg of electrolytes-containing hetastarch (Hextend, Hospira, Inc., Lake Forest, IL) intravenously over 10 to 15 minutes. The MR imagings were obtained at the baseline, at 30 and 60 min later.
Intervention code [1] 256272 0
Treatment: Other
Comparator / control treatment
Clinical study for isobaric spinal anesthesia:
lactated Ringer's solution (crystalloid) vs. electrolytes-containing hextend (colloid).

Volunteer study for MR imaging;
lactated Ringer's solution (crystalloid) vs. electrolytes-containing hextend (colloid).
Control group
Active

Outcomes
Primary outcome [1] 258194 0
In clinical spinal anesthesia study, we investigated whether there is a significant difference in the time to reach the peak sensory block level between the two groups.
Timepoint [1] 258194 0
The sensory block levels were determined by a midline pinprick at 5 min intervals for the first 30 min and then at 15 min intervals until 90 min after the intrathecal injection of 0.5% isobaric tetracaine.
Primary outcome [2] 258195 0
In MR imaging study, we compared cerebrospinal fluid movements at L2-3 intervertebral intrathecal space after administration of either lactated Ringer's solution or electrolytes-containing hextend in order to detect a significant difference in the regurgitant fraction (> 20%) measured at 30 min between the two groups
The definitions of the measured parameters were as follows:
- stroke volume (mL); average of the CSF volume moving caudally during the systole and cranially during the diastole,
- regurgitant fraction (%);ratio of caudal to cranial flow of the CSF per single stroke volume,
- absolute stroke volume (mL); integral over time for the volumetric flow rate,
- mean flux (mL/s); mean velocity X area or the CSF volume that passes the contour per second,
- stroke distance; average of distance of the CSF moving caudally during the systole and cranially during the diastole,
- mean velocity (cm/sec); mean value of distance of CSF movement over time during each cardiac phase,
- maximum amplitude (mL/s); difference between the maximum systolic CSF flux and the maximum diastolic CSF flux.
Timepoint [2] 258195 0
The initial MR images were taken for the baseline. Subsequently 15 mL/kg of lactated Ringer's solution at the first week and electrolytes-containing hextend at the second week was administered over a 10 to 15 min period and MR images were taken 30 and 60 min after the baseline MR images had been taken.
Secondary outcome [1] 263852 0
None
Timepoint [1] 263852 0
.

Eligibility
Key inclusion criteria
In the clinical spinal study, sixty-three patients (American Society of Anesthesiology physical status I and II; aged 70 yr or younger; males and females) scheduled to undergo an elective transurethral resection of a bladder tumor under spinal anesthesia were enrolled in this study. The patients were allocated randomly into one of two groups using a stratified sealed envelope method; crystalloid (sCR) group or colloid (sCO) group.
In MR imaging study, twenty-three healthy male volunteers (age range, 21-26 years), who were free from neurological disease and spinal deformity with no history of medication, were enrolled in this study.
Minimum age
21 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In clinical spinal study, the exclusion criteria included patients who began their procedure after 11:00 AM, who have a history of previous spinal disease or deformities, were unable to communicate due to neurological disease, and other common contraindications for spinal anesthesia.
In MR imaging study, volunteers were involved who were free from neurological disease and spinal deformity with no history of medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 2569 0
Korea, Republic Of
State/province [1] 2569 0

Funding & Sponsors
Funding source category [1] 256759 0
Charities/Societies/Foundations
Name [1] 256759 0
IN-Sung Foundation for Medical Research
Country [1] 256759 0
Korea, Republic Of
Primary sponsor type
Charities/Societies/Foundations
Name
IN-Sung Foundation for Medical Research
Address
IN-Sung Foundation for Medical Research
50th, Ilwon-Dong, Kangnam-Ku,
Seoul, South Korea 135-710
Country
Korea, Republic Of
Secondary sponsor category [1] 256051 0
None
Name [1] 256051 0
Address [1] 256051 0
Country [1] 256051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258795 0
Institutional Review Board at Samsung Medical Center
Ethics committee address [1] 258795 0
Ethics committee country [1] 258795 0
Korea, Republic Of
Date submitted for ethics approval [1] 258795 0
15/05/2008
Approval date [1] 258795 0
29/05/2008
Ethics approval number [1] 258795 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31019 0
Address 31019 0
Country 31019 0
Phone 31019 0
Fax 31019 0
Email 31019 0
Contact person for public queries
Name 14266 0
Byung Seop Shin
Address 14266 0
Dept. of Anesthesiology and Pain Medicine,
50th, Ilwon-Dong, Kangnam-Ku, Seoul,
South Korea 135-710
Country 14266 0
Korea, Republic Of
Phone 14266 0
82-2-3410-0358
Fax 14266 0
82-2-3410-6626
Email 14266 0
[email protected]
Contact person for scientific queries
Name 5194 0
Gaab Soo Kim
Address 5194 0
Dept. of Anesthesiology and Pain Medicine,
50th, Ilwon-Dong, Kangnam-Ku, Seoul,
South Korea 135-710
Country 5194 0
Korea, Republic Of
Phone 5194 0
82-2-3410-0360
Fax 5194 0
82-2-3410-0361
Email 5194 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.