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

Benign Prostate Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483819
• Other study ID #: 4-2015-0362
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: January 24, 2017
• Start date: July 2, 2015
• Est. completion date: February 27, 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 27, 2016
• Est. primary completion date: February 27, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

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