CompletedNCT00772616Updated Sep 23, 2016

Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

A Phase 4 interventional study of Remifentanil and Sufentanil in Anesthesia, sponsored by Hopital Foch. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by Hopital Foch · Phase 4, Interventional, and Basic science

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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. 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 studied

Anesthesia

Keywords

Anesthesia
Analgesia
Patient-Controlled Analgesia
Hyperalgesia

In context

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients scheduled for an abdominal surgery

Exclusion criteria

Exclusion Criteria:

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,
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

Study design

Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 60 participants (actual)

Study arms

Experimental
1
Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).
Drug: Remifentanil
Active comparator
2
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
Drug: Sufentanil

Interventions

DrugRemifentanil
closed-loop administration using bispectral index as the single input for the controller.
DrugSufentanil
dosage according to usual criteria

What researchers measure

Primary outcomes

Dose of morphine administered during the postoperative period (patient controlled analgesia)
Time frame: 48 postoperative hours

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

Study locations

1 site

Hopital Foch
Suresnes, 92150, France

References and documents

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 15983467 ↗
Liu 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00772616
Lead sponsor: Hopital Foch
Responsible party: Sponsor
First posted: Oct 15, 2008
Start date: Sep 2008
Primary completion: Jan 2010
Completion: Jan 2011
Last update: Sep 23, 2016

Study contacts

Marc Fischler, MD

study chair · Hopital Foch

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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