PainDOLANSNCT01303471
Pain Assessment During General Anesthesia
A study testing opioid (remifentanyl) in people with Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment. The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pain
- What is being tested?
- opioid (remifentanyl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jan 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients under 55 years-old
- ASA status 1 or 2
- scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medullar surgery, ear, nose or throat surgery or orthopedic surgery)
Who cannot join
- history of cardiac or autonomic disease
- diabetes
- obesity (BMI>30 kg/m2)
- medication altering autonomic nervous system tone
- history of eyes surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study
During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment.
The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time.
Read more
The main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability) and APV (Arterial Pressure Variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level.
Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and that these effects would be blunted or abolished by by adequate analgesia. The current study is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.
- Conditions
- Pain
- Being tested
- opioid (remifentanyl)
- Keywords
- pain assessment, anesthesia, analgesia, opioid, HRV, APV, autonomic nervous system (ANS), pupil size
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid (remifentanyl)Drug
Infusion of remifentanyl (opioid) will be started at different levels for each group of the randomized study : 0 ng/ml (group 0), 1 ng/ml (group 1), 3 ng/ml (group 3) or 4 ng/ml (group 4)
| Study group | Role | What they receive |
|---|---|---|
| opioïd | Experimental | Different levels of remifentanyl of each group during nociceptive stimulation Receives: Drug: opioid (remifentanyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HRV measurements during noxious stimulation
Analyse of HRV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of HRV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the respiratory frequency, which is associated with parasympathetic activity.
Measured: baseline and 5 minutes
change from baseline in APV measurements during noxious stimulation
Analyse of APV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of APV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the arterial pressure, which is associated with parasympathetic activity.
Measured: baseline and 5 minutes
Secondary outcomes (5)
Change from baseline in pupil change during noxious stimulation
pupil size will be monitored and recored using an infrared pupilometry system consisting of a camera, infrared lignt source, video monitor and video processing software, capturing pupil diameter as a real-time analogue signal (rate of 25 Hz). The pupil size variability will be used to estimate pain
Measured: baseline and 5 minutes
change from baseline in heart rate during noxious stimulation
heart rate will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. The heart rate measurement will be used to estimate pain.
Measured: baseline and 5 minutes
Change from baseline in BIS (Bispectral Index) during noxious stimulation
bispectral index will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. BIS will be used to estimate pain
Measured: baseline and 5 minutes
change from baseline in systolic blood pressure during noxious baseline
Systolic blood pressure will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. Systolic blood pressure measurement will be used to estimate pain
Measured: baseline and 5 minutes
Change from baseline in diastolic blood pressure during noxious stimulation
diastolic blood pressure will be recorded before induction of anesthesia, just before nociceptive stimulation, then every 30 seconds up to the end of the five minutes after nociceptive stimulation. diastolic blood pressure will be used to estimate pain
Measured: basline and 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Charier, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303471
- Sponsor's protocol ID
- 1008032
- Other IDs
- 2010-019591-67
- Acronym
- DOLANS
- Status last verified
- May 2012
- First submitted
- 18 Feb 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study
- ClinicalTrials.gov ID
- NCT01303471
- Acronym / sponsor ID
- DOLANS / 1008032
- Conditions
- Pain
- Keywords
- pain assessment, anesthesia, analgesia, opioid, HRV, APV, autonomic nervous system (ANS), pupil size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Feb 2011 (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.
During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment.
The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time.
The main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability) and APV (Arterial Pressure Variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level.
Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and that these effects would be blunted or abolished by by adequate analgesia. The current study is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| opioïd | Experimental | Drug: opioid (remifentanyl)Different levels of remifentanyl of each group during nociceptive stimulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients under 55 years-old
- ASA status 1 or 2
- scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medullar surgery, ear, nose or throat surgery or orthopedic surgery)
Key exclusion criteria (5 listed)
- history of cardiac or autonomic disease
- diabetes
- obesity (BMI>30 kg/m2)
- medication altering autonomic nervous system tone
- history of eyes surgery
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 |
|---|---|---|
| opioid (remifentanyl)Infusion of remifentanyl (opioid) will be started at different levels for each group of the randomized study : 0 ng/ml (group 0), 1 ng/ml (group 1), 3 ng/ml (group 3) or 4 ng/ml (group 4) | Drug | opioïd |
Primary outcome
Change from baseline in HRV measurements during noxious stimulation
Time frame: baseline and 5 minutes
Analyse of HRV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of HRV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the respiratory frequency, which is associated with parasympathetic activity.
change from baseline in APV measurements during noxious stimulation
Time frame: baseline and 5 minutes
Analyse of APV is a widely used, non-invasive technique to assess autonomic nervous system (ANS) activity. The typical spectral pattern of APV includes two main spectral peaks : a low-freqency (LF) region, affected by both sympathetic and parasympathic activity, and a high-frequency (HF) peak centered at the arterial pressure, which is associated with parasympathetic activity.
5 secondary outcomes
Change from baseline in pupil change during noxious stimulation
Time frame: baseline and 5 minutes
change from baseline in heart rate during noxious stimulation
Time frame: baseline and 5 minutes
Change from baseline in BIS (Bispectral Index) during noxious stimulation
Time frame: baseline and 5 minutes
change from baseline in systolic blood pressure during noxious baseline
Time frame: baseline and 5 minutes
Change from baseline in diastolic blood pressure during noxious stimulation
Time frame: basline and 5 minutes
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 17 May 2012.
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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.
David Charier principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioid (remifentanyl) in people with Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 5 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 17 May 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 France. 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?
Change from baseline in HRV measurements during noxious stimulation (time frame: baseline and 5 minutes). The study lists 2 primary outcomes in all. 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 17 May 2012.