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

Bladder Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221829
• Other study ID #: U/2/2017
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2017
• Last updated: July 14, 2017
• Start date: July 6, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: Medical University of Warsaw
• Contact: Karolina Dobronska, MD, PhD
• Phone: 48 501 323 534
• Email: karolinadobronska[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• TURBT procedure

• spinal anaesthesia

• age over 60

Exclusion Criteria:

• general anaesthesia

Related Conditions & MeSH terms

• Bladder Tumor
• Spinal Anaesthesia
• Transurethral Resection
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Poland	I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

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