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Effect of Epidural Analgesia on Burst Suppression

NCT05688449 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-01-18

No results posted yet for this study

Summary

It has been shown in previous studies that burst suppression has an effect on the development of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). With the development of technology, EEG-based anesthesia management is getting more and more attention. In particular, methods that reduce anesthetic drug consumption are expected to prevent POD and POCD by reducing burst suppression. There are studies that show that epidural analgesia applications reduce general anesthesia drug consumption in patients receiving general anesthesia. In this study, investigators want to investigate the effect of epidural analgesia combined with general anesthesia on burst suppression. POD and POCD development in these patients will be examined as secondary objectives.

Conditions

  • Post-operative Delirium
  • Cognitive Dysfunction
  • Electroencephalography

Interventions

DRUG

Bupivacaine-fentanyl

A 20 ml bolus of 2 mcg/ml fentanyl + 0.125% bupivacaine solution will be administered to the bupivacaine group via the epidural catheter, and 5ml/hour infusion will be started.

DRUG

Saline

A 20 ml bolus of saline will be administered to the saline group via the epidural catheter, and 5ml/hour infusion will be started.

Sponsors & Collaborators

  • Bezmialem Vakif University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-30
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05688449 on ClinicalTrials.gov