The Effect of Nimodipine on the Postoperative Cognitive Dysfunction
Primary Purpose
Mild Cognitive Impairment
Status
Terminated
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Nimodipine group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Postoperative cognitive dysfunction, Nimodipin, Anesthesia
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nimodipine group
Control group
Arm Description
1 tbl of 30 mg nimodipine will be administered orally with premedication
1 tbl of placebo will be administered orally with premedication
Outcomes
Primary Outcome Measures
Change in cognitive behavior
measured by Addenbrooks cognitive test
Secondary Outcome Measures
Full Information
NCT ID
NCT02537080
First Posted
August 27, 2015
Last Updated
September 28, 2019
Sponsor
University Hospital Hradec Kralove
1. Study Identification
Unique Protocol Identification Number
NCT02537080
Brief Title
The Effect of Nimodipine on the Postoperative Cognitive Dysfunction
Official Title
The Effect of Nimodipine in the Preoperative Period on the Onset of Postoperative Cognitive Dysfunction in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
higher POCD in nimodipine Group
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Postoperative cognitive dysfunction, Nimodipin, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nimodipine group
Arm Type
Experimental
Arm Description
1 tbl of 30 mg nimodipine will be administered orally with premedication
Arm Title
Control group
Arm Type
Experimental
Arm Description
1 tbl of placebo will be administered orally with premedication
Intervention Type
Drug
Intervention Name(s)
Nimodipine group
Other Intervention Name(s)
nimodipine
Intervention Description
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
Intervention Type
Drug
Intervention Name(s)
Control group
Other Intervention Name(s)
placebo
Intervention Description
the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
Primary Outcome Measure Information:
Title
Change in cognitive behavior
Description
measured by Addenbrooks cognitive test
Time Frame
within the first 3 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlasta Dostalova, MD, PhD
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
12. IPD Sharing Statement
Learn more about this trial
The Effect of Nimodipine on the Postoperative Cognitive Dysfunction
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