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The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Liberal group
Restrictive group
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Postoperative cognitive dysfunction, Blood pressure, Anesthesia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • GCS 15
  • ASA risk I - III
  • planned spinal surgery in the prone position
  • duration of the procedure of 1-3 hours

Exclusion Criteria:

  • hypertension above 180/100 torr preoperatively
  • blood pressure below 130/80 torr preoperatively

Sites / Locations

  • University Hospital Hradec Kralove

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Liberal group

Restrictive group

Arm Description

During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure.

During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure.

Outcomes

Primary Outcome Measures

Change in cognitive behavior
measured by Addenbrooks cognitive test

Secondary Outcome Measures

Full Information

First Posted
August 27, 2015
Last Updated
August 21, 2018
Sponsor
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT02536885
Brief Title
The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction
Official Title
The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2018 (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
Permanent and temporary cognitive impairment in the perioperative period is of great importance to patients. Hypoperfusion due to the intraoperative hypotension is often mentioned as a possible cause of postoperative cognitive dysfunction.
Detailed Description
All patients aged above 60 years undergoing planned spinal surgery in the prone position in the duration of 1-3 hours under general anesthesia will be included in the study. In group L (liberal), the value of blood pressure will be corrected with the change of mean arterial pressure (MAP) ± 25% patient's mean arterial pressure, and group R (restrictive) with the change of MAP ± 10%. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day. 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 syntophyllin, nor pharmacological decurarization (syntostigmin) will be applied to the patients.

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, Blood pressure, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberal group
Arm Type
Experimental
Arm Description
During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure.
Arm Title
Restrictive group
Arm Type
Experimental
Arm Description
During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure.
Intervention Type
Procedure
Intervention Name(s)
Liberal group
Intervention Description
If the pressure decreases below 75% of patient's baseline mean arterial pressure for more than 1 min, continuous application of noradrenalin will be initiated. If the blood pressure increases above 125% of patient's baseline mean arterial pressure for more than 1 min, Ebrantil (urapidil hydrochlorid) will be applied in dose of 5 mg intravenously with the possibility of repeated doses in 2 minutes intervals.
Intervention Type
Procedure
Intervention Name(s)
Restrictive group
Intervention Description
If the pressure decreases below 90% of patient's baseline mean arterial pressure for more than 1 min, continuous application of noradrenalin will be initiated. If the blood pressure increases above 110% of patient's baseline mean arterial pressure for more than 1 min, Ebrantil (urapidil hydrochlorid) will be applied in dose of 5 mg intravenously with the possibility of repeated doses in 2 minutes intervals.
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: GCS 15 ASA risk I - III planned spinal surgery in the prone position duration of the procedure of 1-3 hours Exclusion Criteria: hypertension above 180/100 torr preoperatively blood pressure below 130/80 torr preoperatively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlasta Dostalova, MD, PhD
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia

12. IPD Sharing Statement

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The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

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