The Assessment of POCD After TURBT Under Spinal Anesthesia

Sponsor

Medical University of Warsaw (Other)

Overall Status

Unknown status

CT.gov ID

NCT03029676

Collaborator

(none)

200

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Tumor Postoperative Cognitive Dysfunction	Drug: benzodiazepines Drug: opioid Procedure: spinal anesthesia	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

the participant is not performed about the type of premedication performed

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Jun 30, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Group B

spinal anesthesia premedication with benzodiazepine and opioid

Drug: benzodiazepines

sedative

Other Names:

midazolam

Drug: opioid

analgetic, sedative

Other Names:

fentanyl

Procedure: spinal anesthesia

Active Comparator: Group K

spinal anesthesia premedication with opioid

Drug: opioid

analgetic, sedative

Other Names:

fentanyl

Procedure: spinal anesthesia

Outcome Measures

Primary Outcome Measures

postoperative cognitive disfunction [6 months]
evaluated by Montreal Cognitive Assesment

Secondary Outcome Measures

the influence of benzodiazepines on POCD [6 months]
evaluated by Montreal Cognitive Assesment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw	Warsaw		Poland	02-005

Sponsors and Collaborators

Medical University of Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karolina Dobrońska, MD, Medical University of Warsaw

ClinicalTrials.gov Identifier:

NCT03029676

Other Study ID Numbers:

U/1/2017

First Posted:

Jan 24, 2017

Last Update Posted:

Jan 24, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karolina Dobrońska, MD, Medical University of Warsaw

spinal anesthesia, TURBT, POCD, premedication

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Postoperative Cognitive Complications

Cognitive Dysfunction

Fentanyl

Midazolam

Study Results

No Results Posted as of Jan 24, 2017