General AnaesthesiaeMACNCT05789992

Evaluation of Equivalent Minimum Alveolar Concentration (eMAC) During Propofol/Remifentanil Anesthesia

A study testing Propofol, Low Remifentanil and Heigh Remifentanil in people with General Anaesthesia, run by Zhang Haopeng at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: General Anaesthesia
What is being tested?: Propofol, Low Remifentanil and Heigh Remifentanil
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteChina
Study dates: 3 Apr 2023to 29 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing elective surgery under general anesthesia;
Patients with ASA rating I~III;
The age of the patient is more than 18 years old;
The informed consent has been signed;

Who cannot join

Patients who are participating in other trials;
Patients with cognitive impairment, mental illness or taking psychotropic drugs within three months;
Patients with a history of stroke;
Patients with a history of alcoholism (long-term drinking more than 5 years, daily white wine consumption ≥ 50ml);
Pregnant women;
Patients with BMI>30;
Patients and family members who are unwilling to participate after understanding the research content;
According to the evaluation of the researcher, the actual condition is not suitable for the patients participating in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Xijing Hospital
Xi'an, Shaanxi

Other trials in China

About this study

Official title: Detection of Nociceptive Stimulation and Anesthesia State by Equivalent Minimum Alveolar Concentration (eMAC) During Anesthesia With Varying Propofol and Remifentanil Concentrations

The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.

Read the detailed description

eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.

Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation (5s, 50mA) and intubation. The concentration combinations include the electrical stimulation combination (effector chamber concentration random: remifentanil 0-3 ng/ml, propofol 3-5 ug/ml) and the intubation combination (effector chamber concentration random: remifentanil 3-5 ng/ml, propofol 3-5 ug/ml). All combinations were decided before operation. Every combination had a 5 min equilibration period, and the vital signs (Heart Rate, Blood pressure, any body movement) and BIS, eMAC will be recorded before and after the electrical stimulation and intubation. After this period, patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia, and regular anesthesia is executed. This study only records vital signs and BIS, eMAC during maintenance period of perioperative.

Conditions: General Anaesthesia
Being tested: Propofol, Low Remifentanil, Heigh Remifentanil, Intubation, tetanic electrical stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PropofolDrug
Also called Propofol for tetanic electrical stimulation and intubation
Propofol (Random:3-5ug/ml)
Low RemifentanilDrug
Also called Remifentanil for tetanic electrical stimulation
Remifentanil (Random:0-3ug/ml)
Heigh RemifentanilDrug
Also called Remifentanil for intubation
Remifentanil (Random:3-5ug/ml)
IntubationProcedure or surgery
Endotracheal intubation before surgery
tetanic electrical stimulationProcedure or surgery
tetanic electrical stimulation before surgery

Study groups in NCT05789992
Study group	Role	What they receive
Group 1 BIS under tetanic electrical stimulation	Active comparator	During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS. Receives: Drug: Propofol; Drug: Low Remifentanil; Procedure: tetanic electrical stimulation
Group 2 eMAC under tetanic electrical stimulation	Active comparator	During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC. Receives: Drug: Propofol; Drug: Low Remifentanil; Procedure: tetanic electrical stimulation
Group 3 BIS under intubation	Active comparator	During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS. Receives: Drug: Propofol; Drug: Heigh Remifentanil; Procedure: Intubation
Group 4 eMAC under intubation	Active comparator	During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC. Receives: Drug: Propofol; Drug: Heigh Remifentanil; Procedure: Intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

Prediction probability of eMAC
Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween eMAC and the lable of response was calculated.
Measured: 1 year

Secondary outcomes (1)

Prediction probability of BIS
Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween BIS and the lable of response was calculated.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 202329 Apr 2023

First posted29 Mar 2023
Study start3 Apr 2023
Primary completion29 Apr 2023
Study completion29 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for General AnaesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05789992
Sponsor's protocol ID: 202302
Acronym: eMAC
Status last verified: Jun 2023
First submitted: 2 Mar 2023
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368.
PubMed 20216387
Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
PubMed 23471754
Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef.
PubMed 19741484
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.
PubMed 40244902

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Detection of Nociceptive Stimulation and Anesthesia State by Equivalent Minimum Alveolar Concentration (eMAC) During Anesthesia With Varying Propofol and Remifentanil Concentrations
ClinicalTrials.gov ID: NCT05789992
Acronym / sponsor ID: eMAC / 202302
Conditions: General Anaesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Zhang HaopengUniversity, hospital or other
Study start: 3 Apr 2023 (actual)
Primary completion: 29 Apr 2023 (actual)
Study completion: 29 Apr 2023 (actual)
First posted: 29 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.

Detailed description

eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1 BIS under tetanic electrical stimulation	Active comparator	Drug: Propofol, Drug: Low Remifentanil, Procedure: tetanic electrical stimulationDuring tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
Group 2 eMAC under tetanic electrical stimulation	Active comparator	Drug: Propofol, Drug: Low Remifentanil, Procedure: tetanic electrical stimulationDuring tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
Group 3 BIS under intubation	Active comparator	Drug: Propofol, Drug: Heigh Remifentanil, Procedure: IntubationDuring intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
Group 4 eMAC under intubation	Active comparator	Drug: Propofol, Drug: Heigh Remifentanil, Procedure: IntubationDuring intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients undergoing elective surgery under general anesthesia;
Patients with ASA rating I~III;
The age of the patient is more than 18 years old;
The informed consent has been signed;

Key exclusion criteria (8 listed)

Patients who are participating in other trials;
Patients with cognitive impairment, mental illness or taking psychotropic drugs within three months;
Patients with a history of stroke;
Patients with a history of alcoholism (long-term drinking more than 5 years, daily white wine consumption ≥ 50ml);
Pregnant women;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PropofolAlso: Propofol for tetanic electrical stimulation and intubationPropofol (Random:3-5ug/ml)	Drug	Group 1 BIS under tetanic electrical stimulation, Group 2 eMAC under tetanic electrical stimulation, Group 3 BIS under intubation, Group 4 eMAC under intubation
Low RemifentanilAlso: Remifentanil for tetanic electrical stimulationRemifentanil (Random:0-3ug/ml)	Drug	Group 1 BIS under tetanic electrical stimulation, Group 2 eMAC under tetanic electrical stimulation
Heigh RemifentanilAlso: Remifentanil for intubationRemifentanil (Random:3-5ug/ml)	Drug	Group 3 BIS under intubation, Group 4 eMAC under intubation
IntubationEndotracheal intubation before surgery	Procedure or surgery	Group 3 BIS under intubation, Group 4 eMAC under intubation
tetanic electrical stimulationtetanic electrical stimulation before surgery	Procedure or surgery	Group 1 BIS under tetanic electrical stimulation, Group 2 eMAC under tetanic electrical stimulation

Primary outcome

Prediction probability of eMAC
Time frame: 1 year
Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween eMAC and the lable of response was calculated.

1 secondary outcome

Prediction probability of BIS
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Background: PubMed 20216387Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368.
Background: PubMed 23471754Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
Background: PubMed 19741484Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef.
Derived from this study: PubMed 40244902Zhang 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.
For PubMed ID: 20216387Link provided by the sponsor.
For PubMed ID: 19741484Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haopeng Zhang, Dr principal investigator

Xijing Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Propofol, Low Remifentanil and Heigh Remifentanil in people with General Anaesthesia, run by Zhang Haopeng at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction probability of eMAC (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05789992, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.