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

NCT03221829 | Unknown

• 1 other identifier: U/2/2017
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anaesthesia; Bladder Tumor; Transurethral Resection

Keywords

spinal anaesthesia; elderly patients; transurethral resection of bladder tumour

Outcome Measures

Primary Outcomes (1)

• 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 .

  The investigator evaluates whether the procedure could be completely performed under spinal anesthesia

  6 months

Secondary Outcomes (4)

• The influence of the bupivacaine spinal dose on bradycardia evaluated by a heart rate measurements

  6 months

• The influence of the bupivacaine dose on hypotension evaluated by the non-invasive blood pressure measurements

  6 months

• Experienced and non-experienced anesthetist does it influence the bupivacaine dose

  6 months

• Experienced and non-experienced anesthetist does it influence the spinal anaesthesia success

  6 months

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• TURBT procedure
• spinal anaesthesia
• age over 60

You may not qualify if:

• general anaesthesia

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw

Warsaw, 02-005, Poland

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Karolina Dobronska, MD, PhD

CONTACT

48 501 323 534; karolinadobronska@gmail.com

Lidia I Jureczko, MD, PhD

CONTACT

48 501 054 419; jureczko@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 19, 2017
• Study Start: July 6, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

PL (1)