The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction
The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 22, 2018
August 1, 2018
2.8 years
August 27, 2015
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in cognitive behavior
measured by Addenbrooks cognitive test
within the first 3 days after surgery
Study Arms (2)
Liberal group
EXPERIMENTALDuring the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure.
Restrictive group
EXPERIMENTALDuring the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- GCS 15
- ASA risk I - III
- planned spinal surgery in the prone position
- duration of the procedure of 1-3 hours
You may not qualify if:
- hypertension above 180/100 torr preoperatively
- blood pressure below 130/80 torr preoperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vlasta Dostalova, MD, PhD
University Hospital Hradec Kralove
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dostalova Vlasta, MD, PhD
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 1, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2018
Study Completion
July 1, 2018
Last Updated
August 22, 2018
Record last verified: 2018-08