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

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

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

elderly patients undergoing transurethral resection of the prostate under spinal anesthesia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients	(Cardiac output, stroke volume, Stroke volume index, Total peripheral resistance, heart rate, blood pressure)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
estimated absorbed irrigation fluid during the surgery	Fluid absorbed = % decrease in sodium x ECF (0.2 x body weight)	during the surgery
incidence of TURP syndrome		followed for the duration of hospital stay, an expected average of 7 days.

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2015
• Primary Completion (Actual): February 27, 2016
• Study Completion (Actual): February 27, 2016

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Elderly patient; TURP; NICOM
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 4-2015-0362