Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772616
• Other study ID #: 2007/13
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2008
• Last updated: September 22, 2016
• Start date: September 2008
• Est. completion date: January 2011

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for an abdominal surgery

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Remifentanil
closed-loop administration using bispectral index as the single input for the controller.
• Sufentanil
dosage according to usual criteria

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of morphine administered during the postoperative period (patient controlled analgesia)		48 postoperative hours	No
Secondary	postoperative pain scores		48 postoperative hours	No
Secondary	postoperative hyperalgesia		up to 5th to 7th postoperative days	No
Secondary	nausea vomiting		48 postoperative hours	No