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Clinical Trials/NCT02536885
NCT02536885
Completed
Not Applicable

The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults

University Hospital Hradec Kralove1 site in 1 country100 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
University Hospital Hradec Kralove
Enrollment
100
Locations
1
Primary Endpoint
Change in cognitive behavior
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dostalova Vlasta, MD, PhD

Dostalova Vlasta, MD, PhD

University Hospital Hradec Kralove

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in cognitive behavior

Time Frame: within the first 3 days after surgery

measured by Addenbrooks cognitive test

Study Sites (1)

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