TuPASProject: Turkish Precision Anaesthesia Study Project

• Sponsor: Istanbul University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05872529
• Collaborator: Ankara University (Other), Marmara University (Other), Istanbul University - Cerrahpasa (IUC) (Other), Acibadem University (Other), Cukurova University (Other), Saglik Bilimleri Universitesi (Other)
• Enrollment: 2,200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 91.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium; Neurocognitive Disorders	Behavioral: Education	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2200 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Before and After modelBefore and After model
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Turkish Precision Anaesthesia Study Project
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: BEFORE The incidence of the POD and PND will determine before the education which consists processed EEG monitoring and SBI approach
Active Comparator: AFTER The incidence of the POD and PND will determine after the education which consists processed EEG monitoring and SBI approach	Behavioral: Education; The education which consists processed EEG monitoring and SBI approach

Outcome Measures

Primary Outcome Measures

1. The incidence of postoperative delirium [Up to postoperative 3 days]

   POD will be assessed by Nu-DESC

Secondary Outcome Measures

1. The incidence of postoperative neurocognitive disorder [Postoperative Month 3]

   PND will be assessed by WHODAS2

Other Outcome Measures

1. Duration of recovery room stay [24 hours]

   Duration of recovery room stay will be recorded

2. Duration of hospital stay [2 weeks]

   Duration of hospital stay will be recorded

3. Mortality [Postoperative Month 3]

   Mortality will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters	Istanbul		Turkey	34098

Sponsors and Collaborators

• Istanbul University
• Ankara University
• Marmara University
• Istanbul University - Cerrahpasa (IUC)
• Acibadem University
• Cukurova University
• Saglik Bilimleri Universitesi

Investigators

• Principal Investigator: Ozlem Korkmaz Dilmen, Prof, Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty
• Principal Investigator: Basak Ceyda Meco, Prof, Ankara University, Department of Anesthesiology and Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Özlem Korkmaz Dilmen, Prof MD, Istanbul University - Cerrahpasa (IUC)
• ClinicalTrials.gov Identifier: NCT05872529
• Other Study ID Numbers: IREANET001
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Özlem Korkmaz Dilmen, Prof MD, Istanbul University - Cerrahpasa (IUC): Delirium; Neurocognitive Disorders; electroencephalography; Postoperative
• Additional relevant MeSH terms: Delirium; Neurocognitive Disorders

Study Results

No Results Posted as of May 24, 2023