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Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients

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ClinicalTrials.gov Identifier: NCT02483819
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The purpose of this study is to evaluate the change of the hemodynamic profiles on bio reactance technique during TURP in elderly patients.

Condition or disease
Benign Prostate Hyperplasia

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : July 2, 2015
Actual Primary Completion Date : February 27, 2016
Actual Study Completion Date : February 27, 2016



Primary Outcome Measures :
  1. change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients [ Time Frame: change from baseline 1 min before the anesthesia, 10 min after anesthesia, 10 min after surgery, 20 min after surgery, 30 min after surgery, at the end of the surgery ]
    (Cardiac output, stroke volume, Stroke volume index, Total peripheral resistance, heart rate, blood pressure)


Secondary Outcome Measures :
  1. change of the electrolyte [ Time Frame: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery ]
  2. change of the hemoglobin [ Time Frame: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery ]
  3. estimated absorbed irrigation fluid during the surgery [ Time Frame: during the surgery ]
    Fluid absorbed = % decrease in sodium x ECF (0.2 x body weight)

  4. incidence of TURP syndrome [ Time Frame: followed for the duration of hospital stay, an expected average of 7 days. ]


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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
elderly patients undergoing transurethral resection of the prostate under spinal anesthesia
Criteria

Inclusion Criteria:

1) Twenty (ASA status I ~ III) patients, ages 65 to 80 yr old, who were scheduled for transurethral resection of the prostate under spinal anesthesia

Exclusion Criteria:

  1. if there were contraindications for spinal anesthesia including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
  2. history of coronary artery bypass surgery
  3. history of dementia
  4. have a difficulty in understanding informed consent or refuse to sign the informed consent
  5. patients height under 150 cm

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02483819     History of Changes
Other Study ID Numbers: 4-2015-0362
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Yonsei University:
Elderly patient
NICOM
TURP

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male