Turkish Precision Anaesthesia Study Project

NCT05872529 | Unknown

• 1 other identifier: IREANET001
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Neurocognitive Disorders

Keywords

Delirium; Neurocognitive Disorders; electroencephalography; Postoperative

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative delirium

  POD will be assessed by Nu-DESC

  Up to postoperative 3 days

Secondary Outcomes (1)

• The incidence of postoperative neurocognitive disorder

  Postoperative Month 3

Other Outcomes (3)

• Duration of recovery room stay

  24 hours

• Duration of hospital stay

  2 weeks

• Mortality

  Postoperative Month 3

Study Arms (2)

BEFORE

NO INTERVENTION

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

AFTER

ACTIVE COMPARATOR

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

Behavioral: Education

Interventions

Education BEHAVIORAL

The education which consists processed EEG monitoring and SBI approach

AFTER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Ankara University: collaborator
• Marmara University: collaborator
• Istanbul University - Cerrahpasa: collaborator
• Acibadem University: collaborator
• Cukurova University: collaborator
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 35183345 RESULT

• 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.

  PMID: 30336844 RESULT

• 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.

  PMID: 35652170 RESULT

• 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.

  PMID: 23539235 RESULT

MeSH Terms

Conditions

Delirium; Neurocognitive Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ozlem Korkmaz Dilmen, Prof

  Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty

  PRINCIPAL INVESTIGATOR

• Basak Ceyda Meco, Prof

  Ankara University, Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özlem Korkmaz Dilmen, Prof

CONTACT

00904143000; korkmazdilmen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof MD

Model Details: Before and After model

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 24, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)