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

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203290
• Other study ID #: 2018/1377
• Status: Completed
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: March 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Inhalation; Gas
• Respiratory Aspiration

Intervention

Drug:
• Bupivacaine
%0.25 bupivacaine solution
• Sevoflurane
End tidal sevoflurane concentration

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total remifentanil consumption	Total remifentanil consumption when pain index (SPI) is above normal	up to end of the operation
Primary	End tidal volatile anesthetic concentration	End tidal volatile anesthetic concentration that keeps entropy in normal limits	up to 20 minutes
Secondary	Total volatile anesthetic consumption	Amount of total inhalation anesthetic consumed during surgery	up to 2 hours
Secondary	Time to reach target concentration	Time to reach the end tidal anesthetic concentration that we set	up to 10 minutes
Secondary	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	up to 5 minutes
Secondary	The amount of propofol	The amount of using propofol for anesthesia induction	2 minutes

External Links

•   Comparison of the effects of thoracic and lumbar epidural anesthesia on induction and maintenance doses of propofol during total i.v. anesthesia
•   Epidural lidocaine decreases sevoflurane requirement for adequate depth of anesthesia as measured by the BIS monitor