AnesthesiaPhase 4NCT00772616
Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption
A Phase 4 study testing Remifentanil and Sufentanil in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remifentanil and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Jan 2011
- Phase
- Phase 4
- 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 scheduled for an abdominal surgery
Who cannot join
- Age less than 18 years,
- Pregnant women,
- Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- Inflammatory bowel disease,
- Chronic pain,
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- Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
- Alcoholic patients and patients taking opiates,
- History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Intraoperative Analgesia (Sufentanil Administered According to the Usual Criteria or Remifentanil Administered by a Closed-loop System Using Bispectral Index as the Controller) on the Postoperative Morphine Consumption
Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:
- in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
- in the other group, patients will receive propofol and remifentanil both automatically administered.
Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.
- Conditions
- Anesthesia
- Being tested
- Remifentanil, Sufentanil
- Keywords
- Anesthesia, Analgesia, Patient-Controlled Analgesia, Hyperalgesia
- Medical subject headings
- Agnosia, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
closed-loop administration using bispectral index as the single input for the controller.
SufentanilDrug
dosage according to usual criteria
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller). Receives: Drug: Remifentanil |
| 2 | Active comparator | Patients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of morphine administered during the postoperative period (patient controlled analgesia)
Measured: 48 postoperative hours
Secondary outcomes (3)
postoperative pain scores
Measured: 48 postoperative hours
postoperative hyperalgesia
Measured: up to 5th to 7th postoperative days
nausea vomiting
Measured: 48 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772616
- Sponsor's protocol ID
- 2007/13
- Status last verified
- Sep 2016
- First submitted
- 11 Oct 2008
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.
PubMed 15983467Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
PubMed 16571963
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intraoperative Analgesia (Sufentanil Administered According to the Usual Criteria or Remifentanil Administered by a Closed-loop System Using Bispectral Index as the Controller) on the Postoperative Morphine Consumption
- ClinicalTrials.gov ID
- NCT00772616
- Acronym / sponsor ID
- 2007/13
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Analgesia, Patient-Controlled Analgesia, Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Oct 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.
Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:
- in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
- in the other group, patients will receive propofol and remifentanil both automatically administered.
Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RemifentanilPatients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller). |
| 2 | Active comparator | Drug: SufentanilPatients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria |
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 scheduled for an abdominal surgery
Key exclusion criteria (10 listed)
- Age less than 18 years,
- Pregnant women,
- Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- Inflammatory bowel disease,
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 |
|---|---|---|
| Remifentanilclosed-loop administration using bispectral index as the single input for the controller. | Drug | 1 |
| Sufentanildosage according to usual criteria | Drug | 2 |
Primary outcome
Dose of morphine administered during the postoperative period (patient controlled analgesia)
Time frame: 48 postoperative hours
3 secondary outcomes
postoperative pain scores
Time frame: 48 postoperative hours
postoperative hyperalgesia
Time frame: up to 5th to 7th postoperative days
nausea vomiting
Time frame: 48 postoperative hours
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 23 Sep 2016.
- Background: PubMed 15983467Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.
- Background: PubMed 16571963Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
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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.
Marc Fischler, MD study chair
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Sufentanil in people with Anesthesia, run by Hopital Foch 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 10 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 23 Sep 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dose of morphine administered during the postoperative period (patient controlled analgesia) (time frame: 48 postoperative hours). 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 NCT00772616, which also lists 2 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 23 Sep 2016.