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

NCT04203290 | Completed

• 1 other identifier: 2018/1377
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Inhalation; Gas

Keywords

Minumum alveoler concentration; Entropy monitorining; General anesthesia; General anesthesia combined with TEA

Outcome Measures

Primary Outcomes (1)

• End tidal volatile anesthetic concentration

  End tidal volatile anesthetic concentration that keeps entropy in normal limits

  up to 20 minutes

Secondary Outcomes (4)

• Total volatile anesthetic consumption

  up to 2 hours

• Time to reach target concentration

  up to 10 minutes

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

  up to 5 minutes

• The amount of propofol

  2 minutes

Other Outcomes (1)

• Total remifentanil consumption

  up to end of the operation

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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

General anesthesia combined with thoracic epidural anesthesia

ACTIVE COMPARATOR

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: Bupivacaine; Drug: Sevoflurane

Interventions

Bupivacaine DRUG

%0.25 bupivacaine solution

Also known as: marcaine

General anesthesia combined with thoracic epidural anesthesia

Sevoflurane DRUG

End tidal sevoflurane concentration

Also known as: Sevorane

General anesthesia; General anesthesia combined with thoracic epidural anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

İstanbul University

Istanbul, 34050, Turkey (Türkiye)

Location

Related 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

MeSH Terms

Conditions

Respiratory Aspiration; Mucopolysaccharidosis IV

Interventions

Bupivacaine; Sevoflurane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Nuzhet Mert Shenturk, MD, Prof

  Istanbul University Faculty of Medicine Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: December 19, 2019
• Primary Completion: May 20, 2020
• Study Completion: July 20, 2020
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting with the finalisation of the study ; for the next 5 years
• Access Criteria: Will be determined by the institutional ethical committee

Locations

TU (1)