The Assessment of POCD After TURBT Under Spinal Anesthesia

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03029676
• Other study ID #: U/1/2017
• Status: Recruiting
• Phase: Phase 4
• First received: January 20, 2017
• Last updated: January 20, 2017
• Start date: January 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Tumor
• Cognition Disorders
• Postoperative Cognitive Dysfunction
• Urinary Bladder Neoplasms

Intervention

Drug:
• benzodiazepines
sedative
• opioid
analgetic, sedative

Procedure:
• spinal anesthesia

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	postoperative cognitive disfunction	evaluated by Montreal Cognitive Assesment	6 months
Secondary	the influence of benzodiazepines on POCD	evaluated by Montreal Cognitive Assesment	6 months