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End Tidal Anesthetic Concentration in Different Anesthesia Techniques Where Depth of Anesthesia Adjusted With Entropy

Primary Purpose

General Anesthesia, Inhalation; Gas

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Sevoflurane
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for General Anesthesia focused on measuring Minumum alveoler concentration, Entropy monitorining, General anesthesia, General anesthesia combined with TEA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • undergoing major abdominal surgery
  • Patients who will not undergoing operation for thoracic cavity
  • Body Mass Index (BMI) between 20-30

Exclusion Criteria:

  • denial of patients
  • contraindications for thoracic epidural anesthesia
  • patients who are FEV1/FVC < 60
  • patients with thoracic and lomber vertebrae surgery

Sites / Locations

  • İstanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General anesthesia

General anesthesia combined with thoracic epidural anesthesia

Arm Description

Patients will be applyed 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium for anesthesia induction, after intubation sevoflurane will be used for anesthesia maintenance with low flow anesthesia (0.5 l/min).

Before anesthesia induction epidural catheter will be inserted giving 7 ml bupivacaine %0.25 in saline + 50 mcg fentanyl after confirming the location of catheter, following 15 minutes the standard anesthesia induction will be applied ( 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium ). For anesthesia maintenance epidural infusion will be applied ( 7ml/h %0.25 bupivacaine solution) together with low flow (0.5 l/min) sevoflurane anesthesia.

Outcomes

Primary Outcome Measures

End tidal volatile anesthetic concentration
End tidal volatile anesthetic concentration that keeps entropy in normal limits

Secondary Outcome Measures

Total volatile anesthetic consumption
Amount of total inhalation anesthetic consumed during surgery
Time to reach target concentration
Time to reach the end tidal anesthetic concentration that we set
Inhalation anesthetic amount the target concentration reached ( in the period of reaching the set alveolar concentration)
The amount of inhalation anesthetic consumed until reaching the target concentration
The amount of propofol
The amount of using propofol for anesthesia induction

Full Information

First Posted
December 16, 2019
Last Updated
March 16, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04203290
Brief Title
End Tidal Anesthetic Concentration in Different Anesthesia Techniques Where Depth of Anesthesia Adjusted With Entropy
Official Title
Comparison of General Anesthesia and Combined General Thoracic Epidural Anesthesia on End Tidal Volatile Anesthetic Concentration in Cases Which Depth of Anesthesia is Adjusted Using Entropy Monitoring; A Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul 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
The aim of this study is to adjust the end tidal inhalation anesthetic concentration by observing the entropy value in patients who will be provided anesthesia maintenance with volatile anesthetics after applying the routine epidural anesthesia technique and to observe the end tidal volatile concentration that will provide to remain in the target entropy limits during the operation.
Detailed Description
The hypothesis of this study is that in general anesthesia cases which is combined with thoracic epidural anesthesia (TEA), lower alveolar concentration will be required to reach the same anesthesia depth. The main aim of the study is observing and comparing the alveolar concentrations of anesthetic agents with entropy monitoring which is an anesthesia depth monitor in major abdominal surgeries where general anesthesia is combined or not with TEA. In cases where TEA is combined with general anesthesia or not, anesthesia depth will be effectively monitored by entropy monitoring, in this way the adequate depth of anesthesia will be provided with the use of minimal volatile anesthetics and we will be able to prevent the use of large amounts of volatile anesthetics., It will be determined how much reduction in alveolar concentration is required in cases combined with TEA. Nowadays, with the development of reliable anesthesia machines, "low-flow anesthesia" (LFA) is becoming more widespread, and its benefits on patient health, economy and ecology have been demonstrated. In LFA, the depth of anesthesia should not be too superficial or too deep during the time the alveolar concentration of volatile agent reaches equilibrium. Therefore, alveolar concentrations of volatile anesthetics are monitored in modern anesthesia machines. Some machines may also adjust the depth of anesthesia according to the alveolar concentration of the agent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia, Inhalation; Gas
Keywords
Minumum alveoler concentration, Entropy monitorining, General anesthesia, General anesthesia combined with TEA

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
Patients will be applyed 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium for anesthesia induction, after intubation sevoflurane will be used for anesthesia maintenance with low flow anesthesia (0.5 l/min).
Arm Title
General anesthesia combined with thoracic epidural anesthesia
Arm Type
Active Comparator
Arm Description
Before anesthesia induction epidural catheter will be inserted giving 7 ml bupivacaine %0.25 in saline + 50 mcg fentanyl after confirming the location of catheter, following 15 minutes the standard anesthesia induction will be applied ( 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium ). For anesthesia maintenance epidural infusion will be applied ( 7ml/h %0.25 bupivacaine solution) together with low flow (0.5 l/min) sevoflurane anesthesia.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
marcaine
Intervention Description
%0.25 bupivacaine solution
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevorane
Intervention Description
End tidal sevoflurane concentration
Primary Outcome Measure Information:
Title
End tidal volatile anesthetic concentration
Description
End tidal volatile anesthetic concentration that keeps entropy in normal limits
Time Frame
up to 20 minutes
Secondary Outcome Measure Information:
Title
Total volatile anesthetic consumption
Description
Amount of total inhalation anesthetic consumed during surgery
Time Frame
up to 2 hours
Title
Time to reach target concentration
Description
Time to reach the end tidal anesthetic concentration that we set
Time Frame
up to 10 minutes
Title
Inhalation anesthetic amount the target concentration reached ( in the period of reaching the set alveolar concentration)
Description
The amount of inhalation anesthetic consumed until reaching the target concentration
Time Frame
up to 5 minutes
Title
The amount of propofol
Description
The amount of using propofol for anesthesia induction
Time Frame
2 minutes
Other Pre-specified Outcome Measures:
Title
Total remifentanil consumption
Description
Total remifentanil consumption when pain index (SPI) is above normal
Time Frame
up to end of the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: undergoing major abdominal surgery Patients who will not undergoing operation for thoracic cavity Body Mass Index (BMI) between 20-30 Exclusion Criteria: denial of patients contraindications for thoracic epidural anesthesia patients who are FEV1/FVC < 60 patients with thoracic and lomber vertebrae surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuzhet Mert Shenturk, MD, Prof
Organizational Affiliation
Istanbul University Faculty of Medicine Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
İstanbul University
City
Istanbul
ZIP/Postal Code
34050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD of cases included into the study will be shared
IPD Sharing Time Frame
Starting with the finalisation of the study ; for the next 5 years
IPD Sharing Access Criteria
Will be determined by the institutional ethical committee
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/11388531
Description
Epidural lidocaine decreases sevoflurane requirement for adequate depth of anesthesia as measured by the BIS monitor
URL
https://www.ncbi.nlm.nih.gov/pubmed/18534970
Description
Comparison of the effects of thoracic and lumbar epidural anesthesia on induction and maintenance doses of propofol during total i.v. anesthesia

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End Tidal Anesthetic Concentration in Different Anesthesia Techniques Where Depth of Anesthesia Adjusted With Entropy

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