Effect of Epidural Analgesia on Burst Suppression

NCT05688449 | Unknown Phase 4

• 1 other identifier: 20220609
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

burst suppression; delirium; electroencephalography; anesthesia; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• burst suppression

  burst suppression rate

  Form beginning of anesthesia induction to the end of anesthesia(During perioperative period)

Secondary Outcomes (2)

• postoperative two days delirium rate

  Within the first two postoperative days

• Postoperative cognitive dysfunction rate

  Participants will be called for control in the postoperative 1st and 3rd months.

Study Arms (2)

Epidural analgesia

ACTIVE COMPARATOR

Eeg monitoring will be implemented with Sedline monitor(Masimo Irvine CA) 5 minutes before epidural catheter insertion, 30 minutes after epidural catheter insertion, during surgery and 5 minutes after extubation.

Drug: Bupivacaine-fentanyl

placebo

PLACEBO COMPARATOR

Eeg monitoring will be implemented with Sedline monitor (Masimo Irvine CA) 5 minutes before epidural catheter insertion, 30 minutes after epidural catheter insertion, during surgery and 5 minutes after extubation.

Drug: Saline

Interventions

Bupivacaine-fentanyl DRUG

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.

Epidural analgesia

Saline DRUG

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

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status 1-3
• Hip or knee arthroplasty surgery

You may not qualify if:

• severe renal failure (need for renal replacement therapy)
• severe liver failure (child-pudg grade c)
• body mass index \>40
• long-term use of some drugs (sedatives, tricyclic antidepressants, narcotic painkillers)
• having a disease related to the nervous system
• having a psychiatric disease
• having a history of substance abuse
• having consumed 2 or more glasses of alcohol per day in the last 1 year
• contraindications for neuraxial block
• allergy to drugs to be used
• emergency surgeries
• patient's refusal to accept the procedure
• hearing and visual impairment
• anesthesia awareness history
• preoperative delirium

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Hospital

Istanbul, Fatih, 34500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Cognitive Dysfunction; Delirium

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

mustafa gunay

CONTACT

+905363146236; dr.mustafagunay@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: January 18, 2023
• Study Start: July 30, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

TU (1)