NCT07266727

Brief Summary

Several studied shown that when general anesthesia is applied under BIS guidance, anesthetic doses are reduced. Additionally it has been found that the risk of postoperative delirium (POD) is reduced and postoperative recovery is accelerated compared to deeper general anesthesia. Current guidelines recommend EEG-based monitoring techniques to prevent postoperative neurocognitive disorders. In clinical practice anesthetic depth is assessed by the patient's autonomic responses to surgical stimulation (pupil diameter, tear, blood pressure and heart rate increase, etc.), the amount of anesthetic gas measured from the expiratory air, and the interpretation of EEG waves and numerical values calculated from these waves (bispactral index, entropy, patient safety index, etc.). The doses of intravenous anesthetic agents used for anesthesia induction are traditionally determined according to body weight. If general anesthetic doses cannot be titrated appropriately for the patients, especially in the elderly and fragile patient group, serious hemodynamic fluctuations may occur during anesthesia induction. The aim of this study is to investigate whether induction and maintenance of anesthesia using the Kugler EEG Analysis method would improve the quality of postoperative recovery in patients aged 65 years and older.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 24, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

electroencephalogrampostoperative deliriumgeriatric patients

Outcome Measures

Primary Outcomes (1)

  • Postoperative Recovery Quality

    Data of QoR-15 score in the preoperative period and at the 24th hour postoperatively The 15-item Quality of Recovery (QoR-15) score is a patient-reported outcome measure assessing postoperative recovery. Scores range from 0 to 150, with higher scores indicating better quality of recovery.

    24 hours

Secondary Outcomes (1)

  • Postoperative Delirium Evaluation

    48 hours

Study Arms (2)

Conventional Anesthetic Management

Preoperatively, patients were administered the QoR-15 questionnaire and scoring was done according to the Nu-DESC test. Before anesthesia induction, patients will be taught the finger-squeeze test and asked to squeeze the fingers placed in the palm when instructed. If no response is obtained to the test after routine administration of 2 mg/kg propofol and 1.5 mcg/kg fentanyl; 0,5 mg/kg rokuronium administered. Desflurane will be used as maintenance inhalation agent. Hemodynamic parameters and burst suppression time will be recorded at 5-minute intervals during the first 15 minutes after induction and at 15-minute intervals thereafter. At the end of the surgery, the patient will be ready to be sent to the ward with the Modified Aldrete score, and awareness will be assessed with the Modified Brice scale. The QoR-15 questionnaire was repeated at 24 hours postoperatively. For delirium assessment, patients were followed up with the Nu-DESC test for 48 hours postoperatively.

Anesthetic Management with Kugler EEG method

Preoperatively, patients were administered the QoR-15 questionnaire and scoring was done according to the Nu-DESC test. Before anesthesia induction, patients will be taught the finger-squeeze test and asked to squeeze the fingers placed in the palm when instructed.Patients were administered propofol according to the Kugler EEG analysis (to be kept C-D level) If no response is obtained, fentanyl 1,5 mcg/kg, 0,5 mg/kg rocuronium administered. Desflurane will be used as maintenance inhalation agent. Hemodynamic parameters and burst suppression time will be recorded at 5-minute intervals during the first 15 minutes after induction and at 15-minute intervals thereafter. At the end of the surgery, the patient ready to be sent to the ward with the Modified Aldrete score, and awareness will be assessed with the Modified Brice scale. The QoR-15 questionnaire repeated at 24 hours postoperatively. For delirium assessment, patients followed up with the Nu-DESC test for 48 hours postoperatively.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

65 years and older patients

You may qualify if:

  • Patients aged 65 and over
  • Elective patients undergoing general anesthesia
  • EEG monitoring

You may not qualify if:

  • Pediatric patients
  • Patients not giving written consent
  • Emergency cases
  • History of seizure
  • Intracranial surgeries
  • Alcohol and substance addiction
  • Severe cognitive impairment (dementia, Alzheimer's)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

March 4, 2025

Primary Completion

November 4, 2025

Study Completion

November 4, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations