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.

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Key information

Conditions

Benign Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

65 year–80 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.
history of coronary artery bypass surgery
history of dementia
have a difficulty in understanding informed consent or refuse to sign the informed consent
patients height under 150 cm

Treatment and study plan

Primary outcomes

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 outcomes

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
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
estimated absorbed irrigation fluid during the surgery

Time frame: during the surgery

Fluid absorbed = % decrease in sodium x ECF (0.2 x body weight)
incidence of TURP syndrome

Time frame: followed for the duration of hospital stay, an expected average of 7 days.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 29, 2015
Registry last updated: Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed