The Assessment of POCD After TURBT Under Spinal Anesthesia

NCT ID: NCT03029676

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-06-30

Brief Summary

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.

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.

Conditions

Bladder Tumor; Postoperative Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group B

spinal anesthesia premedication with benzodiazepine and opioid

Group Type: EXPERIMENTAL

benzodiazepines

Intervention Type: DRUG

sedative

opioid

Intervention Type: DRUG

analgetic, sedative

spinal anesthesia

Intervention Type: PROCEDURE

Group K

spinal anesthesia premedication with opioid

Group Type: ACTIVE_COMPARATOR

opioid

Intervention Type: DRUG

analgetic, sedative

spinal anesthesia

Intervention Type: PROCEDURE

Interventions

benzodiazepines

sedative

Intervention Type: DRUG

opioid

analgetic, sedative

Intervention Type: DRUG

spinal anesthesia

Intervention Type: PROCEDURE

Other Intervention Names

midazolam; fentanyl

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Karolina Dobrońska

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Facility Contacts

Karolina Dobronska, MD

Role: primary

karolinapladzyk@gmail.com

+48 22 501 17 27

Lidia I Jureczko, PhD MD

Role: backup

jureczko@gmail.com

+48 22 501 17 27

Other Identifiers

U/1/2017

Identifier Type: -

Identifier Source: org_study_id