NCT07197567

Brief Summary

This observational study aims to evaluate the clinical applicability of the Equivalent Minimum Alveolar Concentration (eMAC) parameter during general anesthesia. eMAC is a recently developed index that combines the effects of both inhalational and intravenous anesthetics, providing a unified measure of anesthetic depth. While the traditional Minimum Alveolar Concentration (MAC) is widely used for inhalational agents, it does not reflect intravenous anesthetics or combined techniques such as Combined Intravenous and Inhalational Anesthesia (CIVIA). In this study, adult patients undergoing elective surgery under general anesthesia will be observed. Standard clinical practice will not be altered. Demographic and clinical parameters, including eMAC, MAC, Bispectral Index (BIS), and hemodynamic variables, will be recorded at defined perioperative time points. No experimental drugs or additional procedures will be administered. The primary aim is to investigate the correlation between eMAC and MAC values obtained during anesthesia. Secondary objectives include assessing the relationship between eMAC and BIS values, comparing eMAC, MAC, and BIS across different anesthetic techniques, and evaluating hemodynamic stability in relation to anesthetic depth. The results of this study may contribute to a better understanding of eMAC and its potential role in clinical anesthesia practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

August 31, 2025

Last Update Submit

March 6, 2026

Conditions

Keywords

Equivalent Minimum Alveolar ConcentrationeMACMinimum Alveolar ConcentrationMACBispectral IndexBISAnesthesia DepthCombined Intravenous and Inhalational AnesthesiaCIVIAPropofolSevoflurane

Outcome Measures

Primary Outcomes (1)

  • Correlation between Equivalent Minimum Alveolar Concentration (eMAC) and Minimum Alveolar Concentration (MAC)

    To determine the relationship between eMAC values and conventional MAC values obtained from the anesthesia workstation.

    From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery)

Secondary Outcomes (5)

  • Correlation between eMAC and Bispectral Index (BIS)

    From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery)

  • Comparison of eMAC, MAC, and Bispectral Index (BIS) Values Measured by Anesthesia Workstation and BIS Monitor Across Different Anesthetic Techniques

    From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery)

  • Heart Rate During Anesthesia

    From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery)

  • Mean Arterial Pressure During Anesthesia

    From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery)

  • Peripheral Oxygen Saturation (SpO₂) During Anesthesia

    From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery)

Study Arms (2)

Inhalational Anesthesia Group

Patients receiving general anesthesia maintained with inhalational agents (e.g., sevoflurane) according to standard clinical practice.

Drug: Sevoflurane + Remifentanil

Combined Intravenous-Inhalational Anesthesia (CIVIA) Group

Patients receiving general anesthesia with a combination of intravenous and inhalational agents according to standard clinical practice.

Drug: Sevoflurane + Propofol + Remifentanil

Interventions

Combination of an inhalational anesthetic (sevoflurane) and an intravenous opioid analgesic (remifentanil), both routinely used in clinical practice for maintenance of general anesthesia. These agents are administered according to standard of care, not as experimental interventions.

Inhalational Anesthesia Group

Combination of an inhalational anesthetic (sevoflurane), an intravenous anesthetic (propofol), and an intravenous opioid analgesic (remifentanil). These agents are routinely used together in clinical practice for combined intravenous-inhalational anesthesia (CIVIA). All drugs are administered according to standard of care, not as experimental interventions.

Combined Intravenous-Inhalational Anesthesia (CIVIA) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients scheduled for elective surgical procedures under general anesthesia at Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation, will be considered for enrollment. Patients represent a typical surgical population with ASA physical status I-III.

You may qualify if:

  • Adults aged 18-65 years
  • Scheduled for elective surgery under general anesthesia
  • American Society of Anesthesiologists (ASA) Physical Status I-III
  • Feasibility of Bispectral Index (BIS) monitoring
  • Provision of written informed consent

You may not qualify if:

  • History of neurological disease (e.g., epilepsy, dementia, severe brain injury)
  • Known allergy to anesthetic agents
  • Severe cardiovascular or respiratory failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation

Sakarya, Adapazari, Turkey (Türkiye)

Location

Related Publications (1)

  • Zhang H, Zhang J, Li X, He S, Deng Z, Wang L, Wang Y, Wang X, Wan C, Huang F, Zhu Z, Dong H. Feasibility Study of an Indicator of Equivalent Potency of Multiple Anesthetics Normalized by Minimum Alveolar Concentration Derived From Response Surface Models. Anesth Analg. 2026 Mar 1;142(3):541-550. doi: 10.1213/ANE.0000000000007514. Epub 2025 Apr 17.

    PMID: 40244902BACKGROUND

MeSH Terms

Interventions

SevofluraneRemifentanilPropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Ayca Tas Tuna, Professor, M.D.

    Sakarya University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

August 31, 2025

First Posted

September 29, 2025

Study Start

November 1, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because this is a single-center observational study with a limited sample size, and data contain potentially identifiable clinical information. Only aggregated results will be reported in publications.

Locations