The Effect of Nimodipine on the Postoperative Cognitive D... | NCT02537080

Studies
The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

NCT02537080

Sponsor

University Hospital Hradec Kralove

Status

Terminated

Last Update Posted

Oct 1, 2019Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Mild Cognitive Impairment

Interventions

Nimodipine group
Control group

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

higher POCD in nimodipine Group

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Aug 27, 2015

First Submission Date that Met QC Criteria

Aug 31, 2015

First Posted Date

Sep 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2019

Last Update Posted Date

Oct 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dostalova Vlasta, MD, PhD, Vlasta Dostalova, MD, PhD, University Hospital Hradec KralovePrincipal Investigator

Lead Sponsor

University Hospital Hradec KraloveOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly inhibited the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of nitric oxide and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal cytokine networks are important in the development of nerve cell damage that leads to cognitive impairment.

Detailed Description

All patients aged above 60 years undergoing planned neurosurgical operations in the duration up to 4 hours under general anesthesia will be included in the study. The patients will not be sedated by any type of benzodiazepine. A dose of 30 mg nimodipine or placebo will be applied 45 minutes before the surgery according to the randomization. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophylline, nor pharmacological decurarization (syntostigmine) will be applied to the patients.During the surgery, blood pressure will be maintained within ± 15% of the patient's normal blood pressure. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nimodipine group	Experimental	1 tbl of 30 mg nimodipine will be administered orally with premedication	Drug: Nimodipine group
Control group	Experimental	1 tbl of placebo will be administered orally with premedication	Drug: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nimodipine group	Drug	the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure	Nimodipine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cognitive behavior	measured by Addenbrooks cognitive test	within the first 3 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Glascow coma scale GCS 15 preoperatively
American Society of Anesthesiologists ASA risk I - III
planned brain surgery
duration of procedure up to 4 hours.

Exclusion Criteria:

blood pressure below 130/80 torr preoperatively
previous vascular surgery
concomitant use of antiepileptic drugs, rifampicin
allergy to nimodipine
known liver cirrhosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vlasta Dostalova, MD, PhD	University Hospital Hradec Kralove	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Hradec Králové		50005	Czechia

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D000079690	Postoperative Cognitive Complications

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009553	Nimodipine
D035061	Control Groups

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided