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

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

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Inhalation; Gas
• Intervention / Treatment: Drug: Sevoflurane; Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34050
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Drug: Sevoflurane; End tidal sevoflurane concentration; Other Names: Sevorane
ACTIVE_COMPARATOR: 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.	Drug: Sevoflurane; End tidal sevoflurane concentration; Other Names: Sevorane; Drug: Bupivacaine; %0.25 bupivacaine solution; Other Names: marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End tidal volatile anesthetic concentration	End tidal volatile anesthetic concentration that keeps entropy in normal limits	up to 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volatile anesthetic consumption	Amount of total inhalation anesthetic consumed during surgery	up to 2 hours
Time to reach target concentration	Time to reach the end tidal anesthetic concentration that we set	up to 10 minutes
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
The amount of propofol	The amount of using propofol for anesthesia induction	2 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total remifentanil consumption	Total remifentanil consumption when pain index (SPI) is above normal	up to end of the operation

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Nuzhet Mert Shenturk, MD, Prof, Istanbul University Faculty of Medicine Department of Anesthesiology

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 19, 2019
• Primary Completion (ACTUAL): May 20, 2020
• Study Completion (ACTUAL): July 20, 2020

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (ACTUAL): December 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: General anesthesia; Minumum alveoler concentration; Entropy monitorining; General anesthesia combined with TEA
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Local; Anesthetics, Inhalation; Sevoflurane; Bupivacaine
• Other Study ID Numbers: 2018/1377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No