Measure of NociceptionNCT01234194
Composite Variability Index and Propofol Remifentanil Anesthesia
A study testing rising remifentanil concentrations and falling remifentanil concentrations in people with Measure of Nociception, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of the study is to determine if the new Composite Variability Index (CVI) is capable of detecting changing effect compartment concentrations of remifentanil. In addition, it is planed to detect if the change in CVI in response to a standardized painful stimulus is dose-dependent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Measure of Nociception
- What is being tested?
- rising remifentanil concentrations and falling remifentanil concentrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jul 2010
- 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 surgical procedure in general anesthesia
Who cannot join
- Pregnancy, drug abuse, cardiac arrhythmia, obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.
The purpose of the study is to determine if the new Composite Variability Index (CVI) is capable of detecting changing effect compartment concentrations of remifentanil. In addition, it is planed to detect if the change in CVI in response to a standardized painful stimulus is dose-dependent.
Read the detailed description
On the day of surgery, patients receive anesthesia by propofol infusion. As soon as the patient is unresponsive und unconscious (BIS 40-60) and a steady state is achieved, a standardized painful stimulus is applied by electrical stimulation of the ulnar nerve (tetanic stimulation [70 mA], 30 seconds, 50 Hz) in group 1. Thereafter remifentanil is infused to an effect compartment concentration target of 1 ng/ml. The standardized stimulus is applied again as the remifentanil target is reached. This procedure is repeated with remifentanil targets of 2 ng/ml and 3ng/ml. In group 2 remifentanil is targeted to effect compartment concentrations of 3 ng/ml followed by 2,1, and 0 ng/ml.
After measuring the effect of the last painful stimulus the patient is intubated for surgery. Throughout the study the Composite Variability Index and standard monitoring is recorded.
- Conditions
- Measure of Nociception
- Being tested
- rising remifentanil concentrations, falling remifentanil concentrations
- Keywords
- Composite Variability Index, Bispectral Index, Electromyography, Nociception, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rising remifentanil concentrationsDrug
remifentanil effect-compartment concentrations 0,1,2,3 ng/ml
falling remifentanil concentrationsDrug
remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Drug: rising remifentanil concentrations |
| Group 2 | Active comparator | Not described Receives: Drug: falling remifentanil concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measure of NociceptionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Richard K Ellerkmann, M.D., Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234194
- Sponsor's protocol ID
- CVI_2010
- Status last verified
- Sep 2010
- First submitted
- 3 Nov 2010
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.
- ClinicalTrials.gov ID
- NCT01234194
- Acronym / sponsor ID
- CVI_2010
- Conditions
- Measure of Nociception
- Keywords
- Composite Variability Index, Bispectral Index, Electromyography, Nociception, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Nov 2010 (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 purpose of the study is to determine if the new Composite Variability Index (CVI) is capable of detecting changing effect compartment concentrations of remifentanil. In addition, it is planed to detect if the change in CVI in response to a standardized painful stimulus is dose-dependent.
Detailed description
On the day of surgery, patients receive anesthesia by propofol infusion. As soon as the patient is unresponsive und unconscious (BIS 40-60) and a steady state is achieved, a standardized painful stimulus is applied by electrical stimulation of the ulnar nerve (tetanic stimulation [70 mA], 30 seconds, 50 Hz) in group 1. Thereafter remifentanil is infused to an effect compartment concentration target of 1 ng/ml. The standardized stimulus is applied again as the remifentanil target is reached. This procedure is repeated with remifentanil targets of 2 ng/ml and 3ng/ml. In group 2 remifentanil is targeted to effect compartment concentrations of 3 ng/ml followed by 2,1, and 0 ng/ml.
After measuring the effect of the last painful stimulus the patient is intubated for surgery. Throughout the study the Composite Variability Index and standard monitoring is recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: rising remifentanil concentrations |
| Group 2 | Active comparator | Drug: falling remifentanil concentrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgical procedure in general anesthesia
Key exclusion criteria (1 listed)
- Pregnancy, drug abuse, cardiac arrhythmia, obesity
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 |
|---|---|---|
| rising remifentanil concentrationsremifentanil effect-compartment concentrations 0,1,2,3 ng/ml | Drug | Group 1 |
| falling remifentanil concentrationsremifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml | Drug | Group 2 |
Primary outcome
Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus
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 4 Nov 2010.
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.
Richard K Ellerkmann, M.D. principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rising remifentanil concentrations and falling remifentanil concentrations in people with Measure of Nociception, run by University Hospital, Bonn 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 1 inclusion and 1 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 4 Nov 2010. 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?
Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2010.