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Effect of Epidural Analgesia on Burst Suppression

Primary Purpose

Post-operative Delirium, Cognitive Dysfunction, Electroencephalography

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine-fentanyl
Saline
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Delirium focused on measuring burst suppression, delirium, electroencephalography, anesthesia, regional anesthesia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) Physical Status 1-3 Hip or knee arthroplasty surgery Exclusion Criteria: 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

Sites / Locations

  • Bezmialem Vakif University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Epidural analgesia

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

burst suppression
burst suppression rate

Secondary Outcome Measures

postoperative two days delirium rate
Screening of the patients regarding a postoperative delirum by Confusion Assessment Method for the ICU.
Postoperative cognitive dysfunction rate
Screening of the patients regarding a postoperative cognitive dysfunction by the telephone Montreal Cognitive Assessment(t-MoCA)

Full Information

First Posted
November 7, 2022
Last Updated
January 15, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05688449
Brief Title
Effect of Epidural Analgesia on Burst Suppression
Official Title
Investigation of the Effect of Epidural Analgesia Combined With General Anesthesia on Burst Suppression Rate in Electroencephalogram Based Anesthesia Management
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Postoperative delirium (POD) is an acute cognitive disorder characterized by inattention, disorganized thinking, and a fluctuating course that develops over hours or days. Although delirium depends on the type of surgery, it is a common postoperative complication with an incidence of 10%-70%. POD causes an increase in mortality, morbidity and health care costs. Risk factors for POD; age, type and duration of surgery, inadequate pain control, type of anesthesia, anemia, transfusion, and preoperative cognitive impairment. In recent years, it has been emphasized that POD can be reduced with the widespread use of electroencephalogram (EEG) based anesthesia management and optimization of anesthetic drugs according to EEG patterns. EEG consists of 6 waveforms: slow, delta, theta, alpha, beta and gamma. Behavioral and neurophysiological patterns caused by anesthetic drugs are associated with different electroencephalogram waveforms. Recent developments in the introduction of EEG-based monitors have made significant contributions to the understanding of the fundamental changes in brain activity caused by anesthetic agents. Today, there are EEG-based anesthesia depth monitors such as bispectral index (BIS) (Medtronic, USA) or Sedline (Masimo Irvine CA). These monitors make it easier to optimize the depth of anesthesia with the numerical data obtained as a result of some calculations as well as the raw EEG. The burst suppression (BS) pattern on the EEG shows a decrease in brain neuronal activity and metabolic activity. Burst suppression can be induced by anesthetic drugs that modulate γ-aminobutyric acid type A receptors. Although sometimes deliberately induced for therapeutic purposes to treat refractory status epilepticus or increased intracranial pressure, burst suppression is generally considered potentially harmful and should be avoided.Studies conducted in recent years have shown the relationship between intraoperative burst suppression (BS) and POD. POD; It can be reduced by continuous EEG monitoring, reducing the dose of propofol, preferring regional anesthesia, effective postoperative pain control, early mobilization, and early postoperative discharge. Interventions that can reduce the development of postoperative delirium will be important for public health. Epidural analgesia can be used effectively in perioperative analgesia. It has been reported in the literature that epidural analgesia combined with general anesthesia reduces the amount of hypnotic drug required to achieve similar depth of anesthesia compared to general anesthesia alone. There is no study in the literature on whether the combination of epidural analgesia and general anesthesia reduces BS in EEG-based anesthesia applications. Our primary aim in this study is to evaluate whether the combination of general anesthesia and epidural analgesia reduces BS in EEG-based anesthesia in patients undergoing total hip and knee arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Delirium, Cognitive Dysfunction, Electroencephalography
Keywords
burst suppression, delirium, electroencephalography, anesthesia, regional anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural analgesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-fentanyl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
A 20 ml bolus of saline will be administered to the saline group via the epidural catheter, and 5ml/hour infusion will be started.
Primary Outcome Measure Information:
Title
burst suppression
Description
burst suppression rate
Time Frame
Form beginning of anesthesia induction to the end of anesthesia(During perioperative period)
Secondary Outcome Measure Information:
Title
postoperative two days delirium rate
Description
Screening of the patients regarding a postoperative delirum by Confusion Assessment Method for the ICU.
Time Frame
Within the first two postoperative days
Title
Postoperative cognitive dysfunction rate
Description
Screening of the patients regarding a postoperative cognitive dysfunction by the telephone Montreal Cognitive Assessment(t-MoCA)
Time Frame
Participants will be called for control in the postoperative 1st and 3rd months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) Physical Status 1-3 Hip or knee arthroplasty surgery Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mustafa gunay
Phone
+905363146236
Email
dr.mustafagunay@gmail.com
Facility Information:
Facility Name
Bezmialem Vakif University Hospital
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mustafa gunay
Phone
+905363146236
Email
dr.mustafagunay@gmail.com
First Name & Middle Initial & Last Name & Degree
ayla turkoz
First Name & Middle Initial & Last Name & Degree
serdar yesiltas

12. IPD Sharing Statement

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Effect of Epidural Analgesia on Burst Suppression

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