Turkish Precision Anaesthesia Study Project
NCT05872529 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2200
Last updated 2023-05-24
Summary
Postoperative delirium (POD) and postoperative neurocognitive disorder (PND) increase the length of hospital stay, morbidity and mortality, especially in elderly patients. Although several risk factors were determined and incidence trials were performed on the development of POD and PND, there has not yet been a multicentre, large-participant study in Turkish population. The SBI approach monitor, detect and help physicians and all perioperative team members to decrease and avoid the adverse side effects of surgery and anaesthesia. In this "before and after" design trial the incidence of POD and PND will be compared before and after education which consists processed EEG and SBI approach.
The primary aim of the study is to determine the effect of education which consists processed EEG monitoring and regularly assessment of patient's stress, anxiety, pain, nausea, vomiting, thirst, hunger and better communication at the pre- and postoperative period on the incidence of POD. The secondary aim of the study is to assess the effect of the Safe Brain Initiative approach on patients' thirst feeling, stress-anxiety levels, postoperative pain, postoperative nausea and vomiting, well-being, satisfaction, length of PACU or recovery room stay, length of hospital stay, incidence of PND and in hospital and 3-month mortality. Also, the physicians', nurses' and patients satisfaction will be assessed.
Conditions
- Delirium
- Neurocognitive Disorders
Interventions
- BEHAVIORAL
-
Education
The education which consists processed EEG monitoring and SBI approach
Sponsors & Collaborators
-
Ankara University
collaborator OTHER -
Marmara University
collaborator OTHER -
Istanbul University - Cerrahpasa
collaborator OTHER -
Acibadem University
collaborator OTHER -
Cukurova University
collaborator OTHER -
Saglik Bilimleri Universitesi
collaborator OTHER -
Istanbul University
lead OTHER
Principal Investigators
-
Ozlem Korkmaz Dilmen, Prof · Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty
-
Basak Ceyda Meco, Prof · Ankara University, Department of Anesthesiology and Intensive Care
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SCREENING
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-31
- Primary Completion
- 2025-01-31
- Completion
- 2025-07-31
Countries
- Turkey (Türkiye)
Study Locations
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