Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery
NCT ID: NCT03775343
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
75 participants
OBSERVATIONAL
2018-10-06
2023-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing
NCT03175302
Evaluation of the Effect of Cataract Surgery on Cognitive Function in Very Elderly Patients
NCT04047485
Postoperative Cognitive Dysfunction in Elderly
NCT02068742
Implementation of a Cognitive Training Program to Reduce the Risk of Postoperative Cognitive Dysfunction
NCT03620968
Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium
NCT03171766
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background: Postoperative cognitive dysfunction can be a serious complication after surgery and is associated with higher mortality.Several studies have demonstrated that major surgery and patients of older age are risk factors for the incidence of cognitive decline in the postoperative phase. Only a few studies investigated the early postoperative changes in cognitive function (\< 24 hours) after minor, day case surgeries in older patients (≥65 years), demonstrating a higher incidence than observed ≥1 week after surgery.
Aim of the project: This study aimed to investigate changes in cognitive function after minor surgery in an elderly patient cohort.
It is the effort to plan perioperative care that can reduce the incidence of postoperative cognitive dysfunction in elderly.
Hypothesis: The present study support the hypothesis that changes in cognitive function after ocular surgery will be greater in the general anesthesia group compared to the sedoanalgesia group.
Methods:
The study will be conducted as a single center, prospective, observational controlled trial at the Medical University of Vienna, Austria.
This prospective and observational study involves consecutive elderly patients (≥65 years) undergoing a minor surgery using general anesthesia or local anesthesia with sedoanalgesia. Fifty patients, 65 years and older, scheduled for elective minor ocular surgery and 25 participants as control group without surgical intervention will be recruited.
Enrollees will be divided in 3 groups:
25 patients general anaesthesia (GA), 25 patients sedoanalgesia combined with local anaesthesia (SA) and 25 participants as control group(CO) without surgical intervention.
Anesthesia will be induced in a standardized fashion in both groups (GA,SA). At baseline the performance on neurocognitive testing using the Mini Mental State Examination (MMSE) hast to be ≥24, otherwise participants will be excluded.
The design utilizes prospective serial assessments of cognitive status. The participants will be evaluated preoperatively and postoperatively over 3 time-points (preoperatively, 6 and 24 hours after surgery) using the Neurocognitive Test Battery Vienna (NTBV) for cognitive assessment.
At the same time points blood tests for plasma levels of S 100-B, IL-6, CRP, vitamin B 12, vitamin D, homocysteine and folic acid will be taken.
This project will investigate the correlation between perioperative changes in these serum parameters with neurocognitive outcome in the elderly after minor surgery to explore whether the concentrations of these parameters can be used as predictors of postoperative cognitive dysfunction and to provide reference for postoperative cognitive dysfunction prevention, early detection and timely diagnosis and treatment.
Further purpose of this study is to investigate if there is an association between changes in intraoperative cerebral oxygenation, changes in perioperative blood pressure, depth of anaesthesia and the presence of cognitive deterioration after surgery.
It is the effort to plan perioperative care that can reduce the incidence of postoperative changes in cognitive function.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
General Anesthesia
General anesthesia:
25 patients older than 65 years, undergoing elective eye surgery under general anesthesia.
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative.
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.
Neurocognitive Test Battery
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.
Blood sampling
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid
Local anesthesia with sedoanalgesia
25 patients older than 65 years, undergoing elective eye surgery under local anesthesia in combination with sedoanalgesia.
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.
Neurocognitive Test Battery
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.
Blood sampling
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid
Control Group
25 patients, not undergoing any operative intervention. To determine a normal reference value of cognitive functions, a group of 25 individuals without an operative intervention will be recruited as a control group.
Intervention: neurocognitive testing (Neurocognitive Test Battery) at 3 determined time points (0, 6 and 24 hours)
Neurocognitive Test Battery
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neurocognitive Test Battery
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.
Blood sampling
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. scheduled to undergo elective ocular surgery
3. American Society of Anesthesiologists class I, II or III
4. MMSE score ≥ 24
5. The people signed informed consent.
6. Expected surgical duration \<90 minutes
7. Able to follow study instructions.
Exclusion Criteria
2. Emergent nature of the ocular surgery
3. American Society of Anesthesiologists class IV
4. MMSE score \< 24
5. unsigned informed consent
6. Expected surgical duration \>90 minutes
7. Not able to follow study instructions.
8. History of psychiatric or neurologic disorders (epilepsy, trauma, stroke,depressive disorders, hemorrhage, transient ischemic attack
9. Drug or substance abuse history
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marita Windpassinger M.D.
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University Vienna
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
Foki T, Hitzl D, Pirker W, Novak K, Pusswald G, Auff E, Lehrner J. Erratum to: Assessment of individual cognitive changes after deep brain stimulation surgery in Parkinson's disease using the Neuropsychological Test Battery Vienna short version. Wien Klin Wochenschr. 2017 Aug;129(15-16):585-587. doi: 10.1007/s00508-017-1210-2. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1907/2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.