NCT02483819

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

July 2, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

June 18, 2015

Last Update Submit

January 24, 2017

Conditions

Benign Prostate Hyperplasia

Keywords

Elderly patientNICOMTURP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

    during the surgery

  • incidence of TURP syndrome

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

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

elderly patients undergoing transurethral resection of the prostate under spinal anesthesia

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 29, 2015

Study Start

July 2, 2015

Primary Completion

February 27, 2016

Study Completion

February 27, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01