- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03171766
Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium
Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium in Neurosurgical Patients
Study Overview
Status
Detailed Description
Postoperative delirium (POD) is a common problem among elders who undergo surgery and anesthesia, with major health consequences. This investigation is expected to clarify and understand the role of neurocognitive reserve in the occurrence of POD, provide grounds to preoperative cognitive risk stratification and early preventive interventions to improve patients' outcomes. The surgical procedure and anesthesia are stressor events that interact with underlying risk factors and play an important role in the development of POD. Evidence is lacking to make recommendations on anesthesia related perioperative interventions. This investigation will contribute to better understand the association between types of anesthesia, medications, monitoring and other anesthesia related factors that can be a target for preventive interventions. This research will add knowledge and clarify the role of predictors and precipitant factors that might enlighten future research on risk stratification models and interventions, prognostic significance, and treatment implications for POD.
All patients scheduled for Neurosurgery will be approached the day before surgery to assess if inclusion criteria are met and obtain informed consent. If so, preoperative evaluation will be performed by two nurse investigators responsible for admission of patients in the Neurosurgical ward.
The Mini-Cog test and the will be administered before surgery to all participants as cognitive assessment tool. The social-economical status will be evaluated regarding the level of education in years, level of physical activity, occupation, income and number of languages spoken (all categorized with appropriate scales). Also, during the preoperative evaluation, demographic data, alcohol consumption, smoking, use of visual or hearing aids, comorbidities, usual medication and preoperative laboratory test results will be obtained and recorded in a form. On the day of the surgery, as the patient arrives at the Operating Room (OR), the anesthesiologist will check for informed consent and the patient will be monitored with the following with the standard ASA protocol.
The Near-infrared spectroscopy (NIRS) is a technology widely used in clinical investigation as an index of brain and tissue oxygenation. The INVOS© Cerebral/Somatic Oximetry is used in high-risk patients or surgeries to provide continuous, real-time, regional oxygen saturation (rSO2. The monitoring parameters, excluding the INVOS©, will be continuously recorded on the software program RugloopII© Waves (Demed, Genk, Belgium).
In the Post-Anesthesia Care Unit (PACU) the infrared pupillometer will be used to measure the patient pupillary reflexes 15 minutes after admission and before PACU discharge.
All included patients will be followed postoperatively from day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3. The investigator nurse will apply the Nu-DESC daily as a tool to screen delirium. The CAM will be applied to diagnose delirium if the patient is screened with POD. Pain will be evaluated using a standard 100mm VAS for pain (VAS=0 no pain, VAS=100 worst pain). Before hospital discharge all participants will retake the Mini-Cog test and the MMSE.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pedro Amorim, MD
- Phone Number: + 351 22 207 7549
- Email: amorpedro29f@gmail.com
Study Locations
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Porto, Portugal
- Recruiting
- Centro Hospitalar do Porto
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Contact:
- Pedro Amorim, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients aged 65 years or older scheduled for elective Neurosurgery
Exclusion Criteria:
- refusal to give informed consent; inability to understand and cooperate to perform the Mini Cog test, Mini Mental State Examination (MMSE) and Visual Analog Scale (VAS) for pain score (including aphasia, motor disability, major neurocognitive disorder, etc); previous dementia documented on clinical records and Portuguese not first language.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
POD
Time Frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Incidence of Postoperative Disfunction
|
From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Occurrence of In-hospital mortality
|
From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Complications
Time Frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Occurrence of Postoperative complications
|
From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Hospital length of stay
Time Frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Hospital length of stay
|
From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria J Susano, MD, Centro Hospitalar do Porto
- Study Chair: Humberto Machado, PhD, Centro Hospitalar do Porto
- Principal Investigator: Pedro Amorim, MD, Centro Hospitalar do Porto
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016.253(216-DEFI/205-CES)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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