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

NCT ID: NCT04203290

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2020-07-20

Brief Summary

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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

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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.

Conditions

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General Anesthesia Inhalation; Gas

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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General anesthesia

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).

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

End tidal sevoflurane concentration

General anesthesia combined with thoracic epidural anesthesia

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

%0.25 bupivacaine solution

Sevoflurane

Intervention Type DRUG

End tidal sevoflurane concentration

Interventions

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Bupivacaine

%0.25 bupivacaine solution

Intervention Type DRUG

Sevoflurane

End tidal sevoflurane concentration

Intervention Type DRUG

Other Intervention Names

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marcaine Sevorane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Nuzhet Mert Senturk, MD, Prof

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuzhet Mert Shenturk, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Faculty of Medicine Department of Anesthesiology

Locations

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İstanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/11388531

Epidural lidocaine decreases sevoflurane requirement for adequate depth of anesthesia as measured by the BIS monitor

https://www.ncbi.nlm.nih.gov/pubmed/18534970

Comparison of the effects of thoracic and lumbar epidural anesthesia on induction and maintenance doses of propofol during total i.v. anesthesia

Other Identifiers

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2018/1377

Identifier Type: -

Identifier Source: org_study_id

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