Turkish Precision Anaesthesia Study Project

Delirium Clinical Trial

— TuPASProject  

Official title:

Turkish Precision Anaesthesia Study Project

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05872529
• Other study ID #: IREANET001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2023
• Source: Istanbul University
• Contact: Özlem Korkmaz Dilmen, Prof
• Phone: 00904143000
• Email: korkmazdilmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2200
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Neurocognitive Disorders

Intervention

Behavioral:
• Education
The education which consists processed EEG monitoring and SBI approach

Locations

Country	Name	City	State
Turkey	Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters	Istanbul

Sponsors (7)

Lead Sponsor	Collaborator
Istanbul University	Acibadem University, Ankara University, Cukurova University, Istanbul University - Cerrahpasa (IUC), Marmara University, Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 — View 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. — View 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. do — View 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of recovery room stay	Duration of recovery room stay will be recorded	24 hours
Other	Duration of hospital stay	Duration of hospital stay will be recorded	2 weeks
Other	Mortality	Mortality will be recorded	Postoperative Month 3
Primary	The incidence of postoperative delirium	POD will be assessed by Nu-DESC	Up to postoperative 3 days
Secondary	The incidence of postoperative neurocognitive disorder	PND will be assessed by WHODAS2	Postoperative Month 3