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

Completed

• Conditions: Benign Prostate Hyperplasia

• Registration Number: NCT02483819
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-29
• Study Start: 2015-07-02
• Primary Completion: 2016-02-27
• Study Completion: 2016-02-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients	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

Name	Time	Method
estimated absorbed irrigation fluid during the surgery	during the surgery	Fluid absorbed = % decrease in sodium x ECF (0.2 x body weight)
change of the hemoglobin	from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
change of the electrolyte	from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
incidence of TURP syndrome	followed for the duration of hospital stay, an expected average of 7 days.