A Retrospective Analysis of Spinal Anaesthesia for TURBT Procedures in Elderly Patients

July 14, 2017 updated by: Karolina Dobrońska, Medical University of Warsaw

A Retrospective Analysis of Spinal Anaesthesia for Transurethral Resection of Bladder Tumour in Elderly Patients: A Single Centre Experience From 2007 to 2017

The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age of most patients is above 60, which increases the risk of complications during the perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional, mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining logical communication with a patient during the procedure enables early diagnosis of complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. The simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

2800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-005
        • Recruiting
        • I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karolina Dobronska, MD
        • Sub-Investigator:
          • Lidia I Jureczko, PhD MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients that have TURBT procedure under spinal anaesthesia in the Urology Departament (Medical University of Warsaw) 2007-2017

Description

Inclusion Criteria:

  • TURBT procedure
  • spinal anaesthesia
  • age over 60

Exclusion Criteria:

  • general anaesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of spinal anaesthesia for TURBT evaluated by a number of participants that had the procedure done, without the need of conversion to general anaesthesia .
Time Frame: 6 months
The investigator evaluates whether the procedure could be completely performed under spinal anesthesia
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence of the bupivacaine spinal dose on bradycardia evaluated by a heart rate measurements
Time Frame: 6 months
The investigator evaluates the bupivacaine doses, heart rate and the need to give atropine
6 months
The influence of the bupivacaine dose on hypotension evaluated by the non-invasive blood pressure measurements
Time Frame: 6 months
The investigator evaluates the bupivacaine doses, blood pressure and the need to give ephedrine
6 months
Experienced and non-experienced anesthetist does it influence the bupivacaine dose
Time Frame: 6 months
The investigator evaluates the doses of bupivacaine spinal given by specialist, young and advanced trainee.
6 months
Experienced and non-experienced anesthetist does it influence the spinal anaesthesia success
Time Frame: 6 months
The investigator evaluates the success rate of spinal anaesthesia given by specialist, young and advanced trainee.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U/2/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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