Turkish Precision Anaesthesia Study Project

NCT05872529 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2200

Last updated 2023-05-24

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872529 on ClinicalTrials.gov