The Assessment of POCD After TURBT Under Spinal Anesthesia

NCT03029676 | Unknown Phase 4

• 1 other identifier: U/1/2017
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Tumor; Postoperative Cognitive Dysfunction

Keywords

spinal anesthesia, TURBT, POCD, premedication

Outcome Measures

Primary Outcomes (1)

• postoperative cognitive disfunction

  evaluated by Montreal Cognitive Assesment

  6 months

Secondary Outcomes (1)

• the influence of benzodiazepines on POCD

  6 months

Study Arms (2)

Group B

EXPERIMENTAL

spinal anesthesia premedication with benzodiazepine and opioid

Drug: benzodiazepines; Drug: opioid; Procedure: spinal anesthesia

Group K

ACTIVE COMPARATOR

spinal anesthesia premedication with opioid

Drug: opioid; Procedure: spinal anesthesia

Interventions

benzodiazepines DRUG

sedative

Also known as: midazolam

Group B

opioid DRUG

analgetic, sedative

Also known as: fentanyl

Group B; Group K

spinal anesthesia PROCEDURE

Group B; Group K

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

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; Postoperative Cognitive Complications

Interventions

Benzodiazepines; Midazolam; Analgesics, Opioid; Fentanyl; Anesthesia, Spinal

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; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant is not performed about the type of premedication performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)