Mild Cognitive ImpairmentNCT02536885
The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction
A study testing Liberal group and Restrictive group in people with Mild Cognitive Impairment, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Liberal group and Restrictive group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GCS 15
- ASA risk I - III
- planned spinal surgery in the prone position
- duration of the procedure of 1-3 hours
Who cannot join
- hypertension above 180/100 torr preoperatively
- blood pressure below 130/80 torr preoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Liberal group, Restrictive group
- Keywords
- Postoperative cognitive dysfunction, Blood pressure, Anesthesia
- Medical subject headings
- Cognitive Dysfunction, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal groupProcedure or surgery
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.
Restrictive groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Liberal group | Experimental | During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure. Receives: Procedure: Liberal group |
| Restrictive group | Experimental | During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure. Receives: Procedure: Restrictive group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive behavior
measured by Addenbrooks cognitive test
Measured: within the first 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Vlasta Dostalova, MD, PhD, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536885
- Sponsor's protocol ID
- 201508-S21P
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults
- ClinicalTrials.gov ID
- NCT02536885
- Acronym / sponsor ID
- 201508-S21P
- Conditions
- Mild Cognitive Impairment
- Keywords
- Postoperative cognitive dysfunction, Blood pressure, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal group | Experimental | Procedure: Liberal groupDuring the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure. |
| Restrictive group | Experimental | Procedure: Restrictive groupDuring the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- GCS 15
- ASA risk I - III
- planned spinal surgery in the prone position
- duration of the procedure of 1-3 hours
Key exclusion criteria (2 listed)
- hypertension above 180/100 torr preoperatively
- blood pressure below 130/80 torr preoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberal groupIf 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. | Procedure or surgery | Liberal group |
| Restrictive groupIf 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. | Procedure or surgery | Restrictive group |
Primary outcome
Change in cognitive behavior
Time frame: within the first 3 days after surgery
measured by Addenbrooks cognitive test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vlasta Dostalova, MD, PhD principal investigator
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal group and Restrictive group in people with Mild Cognitive Impairment, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive behavior (time frame: within the first 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.