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Turkish Precision Anaesthesia Study Project (TuPASProject)

Primary Purpose

Delirium, Neurocognitive Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Delirium focused on measuring Delirium, Neurocognitive Disorders, electroencephalography, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients over 18 years of age Patients who will scheduled for non-cardiac, non-cranial surgery under general anaesthesia Patients who will undergo intraoperative processed EEG monitoring Exclusion Criteria: Patients who will undergo outpatient, cardiac or intracranial surgery Patients undergoing surgery with regional anesthesia Alzheimer disease Psychiatric disorder Using antipsychotic drug Who will refuse to participate in study w Who scheduled for a second surgery within 3 months Who admitted to the ICU postoperatively with intubated and sedated

Sites / Locations

  • Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

BEFORE

AFTER

Arm Description

The incidence of the POD and PND will determine before the education which consists processed EEG monitoring and SBI approach

The incidence of the POD and PND will determine after the education which consists processed EEG monitoring and SBI approach

Outcomes

Primary Outcome Measures

The incidence of postoperative delirium
POD will be assessed by Nu-DESC

Secondary Outcome Measures

The incidence of postoperative neurocognitive disorder
PND will be assessed by WHODAS2

Full Information

First Posted
May 3, 2023
Last Updated
May 23, 2023
Sponsor
Istanbul University
Collaborators
Ankara University, Marmara University, Istanbul University - Cerrahpasa (IUC), Acibadem University, Cukurova University, Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05872529
Brief Title
Turkish Precision Anaesthesia Study Project
Acronym
TuPASProject
Official Title
Turkish Precision Anaesthesia Study Project
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Ankara University, Marmara University, Istanbul University - Cerrahpasa (IUC), Acibadem University, Cukurova University, Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
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 EJA guideline recommends depth of anaesthesia monitoring, especially in frail patients since intraoperative burst suppression increases the risk of PND. American guideline emphasizes that the effect of processed EEG monitoring on POD cannot be fully demonstrated, but it may reduce PND. Yet, processed EEG monitors, when simplified to an index number, may not accurately reflect the depth of anaesthesia. To detect vulnerable patients, EEG training can be easily implemented. Thus, the incidence of POD and PND may decrease. Additionally, not just EEG monitoring but also regular assessment of patients' stress, anxiety, pain, nausea, vomiting, thirst, and hunger during the pre-and postoperative period and better communication with the patients would reduce the risk of POD. That's why we will use the Safe Brain Initiative (SBI) approach. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Neurocognitive Disorders
Keywords
Delirium, Neurocognitive Disorders, electroencephalography, Postoperative

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before and After model
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BEFORE
Arm Type
No Intervention
Arm Description
The incidence of the POD and PND will determine before the education which consists processed EEG monitoring and SBI approach
Arm Title
AFTER
Arm Type
Active Comparator
Arm Description
The incidence of the POD and PND will determine after the education which consists processed EEG monitoring and SBI approach
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
The education which consists processed EEG monitoring and SBI approach
Primary Outcome Measure Information:
Title
The incidence of postoperative delirium
Description
POD will be assessed by Nu-DESC
Time Frame
Up to postoperative 3 days
Secondary Outcome Measure Information:
Title
The incidence of postoperative neurocognitive disorder
Description
PND will be assessed by WHODAS2
Time Frame
Postoperative Month 3
Other Pre-specified Outcome Measures:
Title
Duration of recovery room stay
Description
Duration of recovery room stay will be recorded
Time Frame
24 hours
Title
Duration of hospital stay
Description
Duration of hospital stay will be recorded
Time Frame
2 weeks
Title
Mortality
Description
Mortality will be recorded
Time Frame
Postoperative Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age Patients who will scheduled for non-cardiac, non-cranial surgery under general anaesthesia Patients who will undergo intraoperative processed EEG monitoring Exclusion Criteria: Patients who will undergo outpatient, cardiac or intracranial surgery Patients undergoing surgery with regional anesthesia Alzheimer disease Psychiatric disorder Using antipsychotic drug Who will refuse to participate in study w Who scheduled for a second surgery within 3 months Who admitted to the ICU postoperatively with intubated and sedated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem Korkmaz Dilmen, Prof
Phone
00904143000
Ext
63913
Email
korkmazdilmen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Korkmaz Dilmen, Prof
Organizational Affiliation
Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Basak Ceyda Meco, Prof
Organizational Affiliation
Ankara University, Department of Anesthesiology and Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35183345
Citation
Sumner M, Deng C, Evered L, Frampton C, Leslie K, Short T, Campbell D. Processed electroencephalography-guided general anaesthesia to reduce postoperative delirium: a systematic review and meta-analysis. Br J Anaesth. 2023 Feb;130(2):e243-e253. doi: 10.1016/j.bja.2022.01.006. Epub 2022 Feb 17.
Results Reference
result
PubMed Identifier
30336844
Citation
Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
Results Reference
result
PubMed Identifier
35652170
Citation
Kong H, Xu LM, Wang DX. Perioperative neurocognitive disorders: A narrative review focusing on diagnosis, prevention, and treatment. CNS Neurosci Ther. 2022 Aug;28(8):1147-1167. doi: 10.1111/cns.13873. Epub 2022 Jun 1.
Results Reference
result
PubMed Identifier
23539235
Citation
Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.
Results Reference
result

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Turkish Precision Anaesthesia Study Project

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