The Assessment of POCD After TURBT Under Spinal Anesthesia

January 20, 2017 updated by: Karolina Dobrońska, Medical University of Warsaw

The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia

This study evaluates the influence of premedication on cognitive functions in patients undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of premedication are anxiolysis, analgesia and the reduction of perioperative risk among the patients with comorbidities. The patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Trans-urethral resection of bladder tumor (TURBT) is the basic endoscopic procedure for management of bladder cancer and if there are no contraindications, it is performed under spinal anesthesia. The condition usually occurs among elderly patients, every 9 of 10 is older than 55 years. At this age the postoperative cognitive dysfunction (POCD) is a common complication as the risk increases with age. There are some studies indicating that using benzodiazepines during the perioperative period can also increase the number of registered POCD in patients undergoing anesthesia. Postoperative cognitive dysfunction (POCD) occurs after operations under regional and general anesthesia as well. The study was planed to evaluate the risk of POCD among urological patients and to asses whether combining benzodiazepines with opioids for premedication increases this risk.

The participants after giving the informed consent can participate in the study. The Beck Depression Inventory is performed to rule out the patients with depression. The cognitive functions are tested with Montreal Cognitive Assessment before the surgery and subsequently in the first 24 hours after surgery, three weeks later (while patients come back to receive histopathological examination), and finally six months after surgery (during control cystoscopy).

During anesthesia, the patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized. If the premedication is needed before the surgery the hydroxyzine will be administrated.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consent
  • transurethral resection of the bladder tumor
  • spinal anesthesia

Exclusion Criteria:

Exclusion Criteria:

  • patients' refusal
  • contraindications for spinal anesthesia
  • skin lesions at injection site
  • depression

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group B
spinal anesthesia premedication with benzodiazepine and opioid
Procedure: spinal anesthesia
Drug: benzodiazepines
sedative
Other Names:
  • midazolam
Drug: opioid
analgetic, sedative
Other Names:
  • fentanyl
Active Comparator: Group K
spinal anesthesia premedication with opioid
Procedure: spinal anesthesia
Drug: opioid
analgetic, sedative
Other Names:
  • fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative cognitive disfunction
Time Frame: 6 months
evaluated by Montreal Cognitive Assesment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the influence of benzodiazepines on POCD
Time Frame: 6 months
evaluated by Montreal Cognitive Assesment
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)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U/1/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Postoperative Cognitive Dysfunction

Clinical Trials on spinal anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe