PainNCT00162591
Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl
A study testing remifentanyl in people with Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- remifentanyl
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2004to not given
- 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
- Sedated patient with mechanical ventilation with suspected nosocomial pneumonia
Who cannot join
- Pace maker
- Neurologic illness
- Hemodynamic instability
- Hypothermia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Surgical ICU Bichat Claude Bernard
Paris, 75018
QUINTARD H Hervé, MD, +33140258116, quintard@libertysurf.fr
QUINTARD H Hervé, MD
About this study
The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.
Read the detailed description
Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage.
The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage.
It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients.
The hypothesis is that BIS can study analgesia in sedated patient.
- Conditions
- Pain
- Being tested
- remifentanyl
- Keywords
- Bispectral index, sedation, remifentanyl, Bronchoalveolar lavage, Intensive care, Nociceptive stimuli, Sedated patient, BIS variation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanylDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS variation during bronchoalveolar lavage
Secondary outcomes (1)
Systolic blood pressure, diastolic blood pressure, heart rate viation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- QUINTARD H Hervé, MD, Principal investigator, Surgical ICU Bichat Claude Bernard (Paris, France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162591
- Sponsor's protocol ID
- P040201 AT/AT/04-116
- Status last verified
- Oct 2004
- First submitted
- 10 Sep 2005
- Last updated
- 22 Nov 2005
- Results posted
- No
Publications
Quintard H, Pavlakovic I, Mantz J, Ichai C. Adjunctive remifentanil infusion in deeply sedated and paralyzed ICU patients during fiberoptic bronchoscopy procedure: a prospective, randomized, controlled study. Ann Intensive Care. 2012 Jul 16;2(1):29. doi: 10.1186/2110-5820-2-29.
PubMed 22800647
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl
- ClinicalTrials.gov ID
- NCT00162591
- Acronym / sponsor ID
- P040201 AT/AT/04-116
- Conditions
- Pain
- Keywords
- Bispectral index, sedation, remifentanyl, Bronchoalveolar lavage, Intensive care, Nociceptive stimuli, Sedated patient, BIS variation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2004
- First posted
- 13 Sep 2005 (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 protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.
Detailed description
Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage.
The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage.
It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients.
The hypothesis is that BIS can study analgesia in sedated patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sedated patient with mechanical ventilation with suspected nosocomial pneumonia
Key exclusion criteria (4 listed)
- Pace maker
- Neurologic illness
- Hemodynamic instability
- Hypothermia
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 |
|---|---|---|
| remifentanyl | Drug | – |
Primary outcome
BIS variation during bronchoalveolar lavage
1 secondary outcome
Systolic blood pressure, diastolic blood pressure, heart rate viation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2005.
- Derived from this study: PubMed 22800647Quintard H, Pavlakovic I, Mantz J, Ichai C. Adjunctive remifentanil infusion in deeply sedated and paralyzed ICU patients during fiberoptic bronchoscopy procedure: a prospective, randomized, controlled study. Ann Intensive Care. 2012 Jul 16;2(1):29. doi: 10.1186/2110-5820-2-29.
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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.
QUINTARD H Hervé, MD principal investigator
Surgical ICU Bichat Claude Bernard (Paris, France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remifentanyl in people with Pain, run by Assistance Publique - Hôpitaux de Paris 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 1 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 22 Nov 2005. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact QUINTARD h Hervé, MD (+33140258816, quintard@libertysurf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS variation during bronchoalveolar lavage. 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 NCT00162591, which also lists 1 linked publication.
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 22 Nov 2005.