The Assessment of POCD After TURBT Under Spinal Anesthesia

Phase 4

• Conditions: Postoperative Cognitive Dysfunction; Bladder Tumor
• Interventions: Drug: benzodiazepines; Drug: opioid; Procedure: spinal anesthesia

• Registration Number: NCT03029676
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01-01
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-20
• Last Update Submitted: 2017-01-20
• Study First Posted: 2017-01-24
• Last Update Posted: 2017-01-24
• Primary Completion: 2017-12-31
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	benzodiazepines	spinal anesthesia premedication with benzodiazepine and opioid
Group B	opioid	spinal anesthesia premedication with benzodiazepine and opioid
Group B	spinal anesthesia	spinal anesthesia premedication with benzodiazepine and opioid
Group K	opioid	spinal anesthesia premedication with opioid
Group K	spinal anesthesia	spinal anesthesia premedication with opioid

Primary Outcome Measures

Name	Time	Method
postoperative cognitive disfunction	6 months	evaluated by Montreal Cognitive Assesment

Secondary Outcome Measures

Name	Time	Method
the influence of benzodiazepines on POCD	6 months	evaluated by Montreal Cognitive Assesment

Trial Locations

Locations (1)

I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw; 🇵🇱 Warsaw, Poland