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Completed

NCT Number: NCT04203290

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

%0.25 bupivacaine solution

Other names: marcaine

Sevoflurane

Drug

End tidal sevoflurane concentration

Other names: Sevorane

Primary outcomes

  1. End tidal volatile anesthetic concentration

    Time frame: up to 20 minutes

    End tidal volatile anesthetic concentration that keeps entropy in normal limits

Secondary outcomes

  1. Total volatile anesthetic consumption

    Time frame: up to 2 hours

    Amount of total inhalation anesthetic consumed during surgery

  2. Time to reach target concentration

    Time frame: up to 10 minutes

    Time to reach the end tidal anesthetic concentration that we set

  3. Inhalation anesthetic amount the target concentration reached ( in the period of reaching the set alveolar concentration)

    Time frame: up to 5 minutes

    The amount of inhalation anesthetic consumed until reaching the target concentration

  4. The amount of propofol

    Time frame: 2 minutes

    The amount of using propofol for anesthesia induction

Other outcomes

  1. Total remifentanil consumption

    Time frame: up to end of the operation

    Total remifentanil consumption when pain index (SPI) is above normal

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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