Clinical Trials Logo

Clinical Trial Summary

This project will investigate changes in cognitive function in the early postoperative phase (<24 hours) after minor surgery in patients of older age (≥65 years).


Clinical Trial Description

Primary aim of this study is to evaluate changes in cognitive function in the early postoperative phase after minor surgery in patients of older age (≥65 years). 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03775343
Study type Observational
Source Medical University of Vienna
Contact
Status Completed
Phase
Start date October 6, 2018
Completion date August 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT03228446 - The Effects of Attentional Filter Training on Working Memory N/A
Completed NCT04033419 - Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer Phase 2
Terminated NCT05199142 - A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline Phase 1
Active, not recruiting NCT05290233 - Time Restricted Eating Plus Exercise for Weight Management N/A
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Unknown status NCT00696514 - Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People Phase 1
Completed NCT00110604 - The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing N/A
Recruiting NCT06245005 - Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Active, not recruiting NCT05586750 - Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy Phase 4
Completed NCT04386902 - Evaluation of Cognitive State Using Neurosteer EEG System
Recruiting NCT06070818 - Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline N/A
Completed NCT01669915 - A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline N/A
Completed NCT02814526 - Exercise in Adults With Mild Memory Problems N/A
Not yet recruiting NCT06252376 - Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD N/A
Not yet recruiting NCT05928078 - A Home-based e-Health Intervention in the Elderly: MOVI-ageing N/A
Recruiting NCT06318377 - Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals N/A
Recruiting NCT03839784 - Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Completed NCT04537728 - My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices N/A
Active, not recruiting NCT03370796 - Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context N/A