AnalgesiaNCT00791791
Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia
A study testing standardized pain stimulus in people with Analgesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The aim of the present prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- standardized pain stimulus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Nov 2008
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 65 years
- ASA physical status 1-2
- elective surgery in general anesthesia of 1 to 2 hours
- written informed consent
Who cannot join
- pregnancy
- history of cardiac arrhythmia
- presence of any neuromuscular or neurological disease
- use of CNS-active medication or abuse of alcohol or illicit drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, D-24105
About this study
The aim of the present prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia.
Read the detailed description
General anesthesia can be considered as a combination of hypnosis, antinociception and immobility. Whereas monitoring of depth of hypnosis, and muscle relaxation can be regarded as accepted, determination of the nociception is based on clinical signs like somatic or autonomic responses.
Recently, the multivariate surgical stress index (SSI)has been demonstrated to correlate with surgical stress intensity. Thus, SSI might be a useful variable to adjust analgesic drug administration in individual patients.
We want to investigate whether SSI is able to indicate nociception following standardized noxious stimulation during balanced sevoflurane - remifentanil anesthesia.
- Conditions
- Analgesia
- Being tested
- standardized pain stimulus
- Keywords
- Anesthesia General, Anesthetics Inhalation, Stress measurement, Surgical Stress, 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.
standardized pain stimulusProcedure or surgery
a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | increasing remifentanil administration Receives: Procedure: standardized pain stimulus |
| 2 | Other | decreasing remifentanil concentration Receives: Procedure: standardized pain stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI, compared to standard monitoring variables
Measured: during anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
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 AnalgesiaStudies 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
- Enrolment
- 24 participants (actual)
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
- Investigators
- Matthias Gruenewald, MD, Principal investigator, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus KielBerthold Bein, MD, DEAA, Study chair, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791791
- Sponsor's protocol ID
- SSI-134-1
- Status last verified
- Jun 2012
- First submitted
- 14 Nov 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
PubMed 17329347Gruenewald M, Zhou J, Schloemerkemper N, Meybohm P, Weiler N, Tonner PH, Scholz J, Bein B. M-Entropy guidance vs standard practice during propofol-remifentanil anaesthesia: a randomised controlled trial. Anaesthesia. 2007 Dec;62(12):1224-9. doi: 10.1111/j.1365-2044.2007.05252.x.
PubMed 17991257Rehberg B, Grunewald M, Baars J, Fuegener K, Urban BW, Kox WJ. Monitoring of immobility to noxious stimulation during sevoflurane anesthesia using the spinal H-reflex. Anesthesiology. 2004 Jan;100(1):44-50. doi: 10.1097/00000542-200401000-00011.
PubMed 14695723Gruenewald 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 19648155
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
- Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia
- ClinicalTrials.gov ID
- NCT00791791
- Acronym / sponsor ID
- SSI-134-1
- Conditions
- Analgesia
- Keywords
- Anesthesia General, Anesthetics Inhalation, Stress measurement, Surgical Stress, Diagnostic Techniques and Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Nov 2008 (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 the present prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia.
Detailed description
General anesthesia can be considered as a combination of hypnosis, antinociception and immobility. Whereas monitoring of depth of hypnosis, and muscle relaxation can be regarded as accepted, determination of the nociception is based on clinical signs like somatic or autonomic responses.
Recently, the multivariate surgical stress index (SSI)has been demonstrated to correlate with surgical stress intensity. Thus, SSI might be a useful variable to adjust analgesic drug administration in individual patients.
We want to investigate whether SSI is able to indicate nociception following standardized noxious stimulation during balanced sevoflurane - remifentanil anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: standardized pain stimulusincreasing remifentanil administration |
| 2 | Other | Procedure: standardized pain stimulusdecreasing remifentanil concentration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 65 years
- ASA physical status 1-2
- elective surgery in general anesthesia of 1 to 2 hours
- written informed consent
Key exclusion criteria (4 listed)
- pregnancy
- history of cardiac arrhythmia
- presence of any neuromuscular or neurological disease
- use of CNS-active medication or abuse of alcohol or 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 |
|---|---|---|
| standardized pain stimulusa tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus | Procedure or surgery | 1, 2 |
Primary outcome
SSI, compared to standard monitoring variables
Time frame: during anesthesia
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 2012.
- Background: PubMed 17329347Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
- Background: PubMed 17991257Gruenewald M, Zhou J, Schloemerkemper N, Meybohm P, Weiler N, Tonner PH, Scholz J, Bein B. M-Entropy guidance vs standard practice during propofol-remifentanil anaesthesia: a randomised controlled trial. Anaesthesia. 2007 Dec;62(12):1224-9. doi: 10.1111/j.1365-2044.2007.05252.x.
- Background: PubMed 14695723Rehberg B, Grunewald M, Baars J, Fuegener K, Urban BW, Kox WJ. Monitoring of immobility to noxious stimulation during sevoflurane anesthesia using the spinal H-reflex. Anesthesiology. 2004 Jan;100(1):44-50. doi: 10.1097/00000542-200401000-00011.
- Derived from this study: 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.
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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.
Matthias Gruenewald, MD principal investigator
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
Berthold Bein, MD, DEAA study chair
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized pain stimulus in people with Analgesia, 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: finished, 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?
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?
SSI, compared to standard monitoring variables (time frame: during anesthesia). 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 NCT00791791, 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 2012.