Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06844279

Effects of Anesthesia Depth Monitoring on Postoperative Recovery and Cognitive Functions in Older Adults Undergoing Spinal Surgery

Led by Aslıhan Güleç · Updated on 2025-02-28

75

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of different anesthesia depth monitoring methods on postoperative recovery and cognitive functions in patients aged 65 and older undergoing surgery for lumbar or cervical disc herniation. The study focuses on reducing risks like intraoperative hypotension, burst suppression, and postoperative delirium in the geriatric population, a group known to experience higher rates of cognitive decline after surgery. This trial evaluates the use of both standard numerical Bispectral Index (BIS) monitoring and the advanced Density Spectral Array (DSA) mode during anesthesia. Participants are randomly assigned to one of three groups: anesthesia depth monitoring guided by hemodynamic parameters to avoid hypotension, monitoring based on numeric BIS index values, or monitoring using the DSA function of the BIS device. All patients receive general anesthesia with continuous monitoring of blood pressure, heart rate, oxygen levels, and brain activity throughout the surgery. Preoperative evaluations collect information on participants' age, weight, health conditions, medications, mental status, and daily activity. During surgery, non-invasive monitors record vital signs and anesthesia depth continuously from induction to emergence. After surgery, cognitive function and mental status are assessed using the Confusion Assessment Method (CAM) scale at multiple time points up to 48 hours postoperatively. Researchers also track medication consumption and monitor anesthesia emergence and brain activity patterns. All data collected are kept confidential and used solely for research. Participation lasts through surgery and the immediate postoperative period.

CONDITIONS

Brief Title

The Effects of Anesthesia Depth Monitoring on Postoperative Recovery and Cognitive Functions in the Geriatric Patient Population

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 65 years and older
  • Scheduled for elective spinal surgeries
  • ASA physical status I, II, or III
Not Eligible

You will not qualify if you...

  • Emergency surgeries
  • ASA physical status IV or V
  • Diagnosed delirium or dementia
  • Unable to provide consent to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants undergo spinal surgery with anesthesia depth monitored using one of three methods: standard hemodynamic monitoring, numeric BIS index, or Density Spectral Array (DSA) mode. Monitoring aims to minimize intraoperative hypotension, burst suppression, and postoperative delirium.

1 visit (in-person, during surgery)

Post-operative Follow-up

Duration - 48 hours post-surgery

Participants are assessed for postoperative delirium and cognitive function at multiple time points after surgery.

3 visits (at 6, 24, and 48 hours post-surgery)

Trial Site Locations

Total: 1 location

1

Gazi University School of Medicine

Ankara, Turkey (Türkiye), 06560

Actively Recruiting

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Research Team

A

Aslihan Gulec Kilic, MD

G

Gozde Inan, Associate Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium.

César Aldecoa, Gabriella Bettelli, Federico Bilotta...

https://pubmed.ncbi.nlm.nih.gov/28187050

Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial.

Troy S Wildes, Angela M Mickle, Arbi Ben Abdallah...

https://pubmed.ncbi.nlm.nih.gov/30721296

Incidence change of postoperative delirium after implementation of processed electroencephalography monitoring during surgery: a retrospective evaluation study.

Yi-Chen Chen, I-Yin Hung, Kuo-Chuan Hung...

https://pubmed.ncbi.nlm.nih.gov/37794315

Low Frontal Alpha Power Is Associated With the Propensity for Burst Suppression: An Electroencephalogram Phenotype for a "Vulnerable Brain".

Yu Raymond Shao, Pegah Kahali, Timothy T Houle...

https://pubmed.ncbi.nlm.nih.gov/33079876