General AnaesthesiaNCT01522508
Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia
An observational study of General Anaesthesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anaesthesia
- What is being tested?
- tetanic stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Oct 2012
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgery in general anesthesia
Who may be able to join
- age between 18- 65 years,
- ASA physical status I or II,
- elective surgery in general anesthesia planned,
- written informed consent
Who cannot join
- pregnancy,
- history of cardiac arrhythmia,
- presents of any neuromuscular or neurologic disease,
- use of CNS-active medication or abuse of alcohol/illicit drugs -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.
Kiel, 24105
Berthold Bein, MD, PhD, DEAA, +49 431 597 2991, berthold.bein@uksh.de
Matthias Gruenewald, MD
About this study
Official title: Detection of Nociceptive Stimulation by Analgesia Nociception Index (ANI) During Anesthesia With Propofol or Sevoflurane and Varying Remifentanil Concentrations.
The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.
Read the detailed description
Monitoring Antinociception during general anesthesia is still a big challenge in the field and has not become clinical routine yet. Recently, for the Surgical Pleth Index SPI a benefit for the patient in terms of reduction of remifentanil use, less unwanted effects and shorter recovery from anesthesia was reported. However, there are new variables like the ANI that are developed to measure antinociception during anesthesia.
In the present study the investigators want to evaluate, whether ANI detects a painful tetanic stimulus during general anesthesia using propofol or sevoflurane and different concentrations of remifentanil.
- Conditions
- General Anaesthesia
- Being tested
- tetanic stimulation
- Keywords
- Analgesia, Anesthetics, Diagnostic Techniques and Procedures
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetanic stimulationProcedure or surgery
as test stimulus a painful tetanic stimulation is used
| Study group | Role | What they receive |
|---|---|---|
| propofol/remifentanil | patients receive standardized propofol and changing remifentanil concentrations Receives: Procedure: tetanic stimulation | |
| sevoflurane/remifentanil | patients receive standardized sevoflurane and changing remifentanil concentrations Receives: Procedure: tetanic stimulation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Bein, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522508
- Sponsor's protocol ID
- ANI-134-1
- Status last verified
- Jun 2012
- First submitted
- 26 Jan 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gruenewald M, Meybohm P, Ilies C, Hocker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31.
PubMed 19648155Struys MM, Vanpeteghem C, Huiku M, Uutela K, Blyaert NB, Mortier EP. Changes in a surgical stress index in response to standardized pain stimuli during propofol-remifentanil infusion. Br J Anaesth. 2007 Sep;99(3):359-67. doi: 10.1093/bja/aem173. Epub 2007 Jul 3.
PubMed 17609248Gruenewald 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Nociceptive Stimulation by Analgesia Nociception Index (ANI) During Anesthesia With Propofol or Sevoflurane and Varying Remifentanil Concentrations.
- ClinicalTrials.gov ID
- NCT01522508
- Acronym / sponsor ID
- ANI-134-1
- Conditions
- General Anaesthesia
- Keywords
- Analgesia, Anesthetics, Diagnostic Techniques and Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 31 Jan 2012 (estimated)
- 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 prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.
Detailed description
Monitoring Antinociception during general anesthesia is still a big challenge in the field and has not become clinical routine yet. Recently, for the Surgical Pleth Index SPI a benefit for the patient in terms of reduction of remifentanil use, less unwanted effects and shorter recovery from anesthesia was reported. However, there are new variables like the ANI that are developed to measure antinociception during anesthesia.
In the present study the investigators want to evaluate, whether ANI detects a painful tetanic stimulus during general anesthesia using propofol or sevoflurane and different concentrations of remifentanil.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol/remifentanil | – | Procedure: tetanic stimulationpatients receive standardized propofol and changing remifentanil concentrations |
| sevoflurane/remifentanil | – | Procedure: tetanic stimulationpatients receive standardized sevoflurane and changing remifentanil concentrations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery in general anesthesia
Key inclusion criteria (4 listed)
- age between 18- 65 years,
- ASA physical status I or II,
- elective surgery in general anesthesia planned,
- written informed consent
Key exclusion criteria (4 listed)
- pregnancy,
- history of cardiac arrhythmia,
- presents of any neuromuscular or neurologic disease,
- use of CNS-active medication or abuse of alcohol/illicit drugs -
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 |
|---|---|---|
| tetanic stimulationas test stimulus a painful tetanic stimulation is used | Procedure or surgery | propofol/remifentanil, sevoflurane/remifentanil |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
- Background: PubMed 19648155Gruenewald M, Meybohm P, Ilies C, Hocker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31.
- Background: PubMed 17609248Struys MM, Vanpeteghem C, Huiku M, Uutela K, Blyaert NB, Mortier EP. Changes in a surgical stress index in response to standardized pain stimuli during propofol-remifentanil infusion. Br J Anaesth. 2007 Sep;99(3):359-67. doi: 10.1093/bja/aem173. Epub 2007 Jul 3.
- Derived from this study: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anaesthesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Jun 2012. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Gruenewald, MD (+49 431 597 2991, matthias.gruenewald@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522508, which also lists 3 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 2012.