Postoperative Complications Clinical Trial
Official title:
Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium in Neurosurgical Patients
The main goal of the investigation is to identify the incidence of cognitive dysfunction and POD in patients older than 65 years of age undergoing neurosurgical elective surgery and determine if an association between cognitive dysfunction, basal NIRS and POD exists.
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.
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