Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption - Full Text View

Purpose

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.

Condition	Intervention	Phase
Anesthesia	Drug: Remifentanil Drug: Sufentanil	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Morphine sulfate Sufentanil citrate Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:

Dose of morphine administered during the postoperative period (patient controlled analgesia) [ Time Frame: 48 postoperative hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

postoperative pain scores [ Time Frame: 48 postoperative hours ] [ Designated as safety issue: No ]
postoperative hyperalgesia [ Time Frame: up to 5th to 7th postoperative days ] [ Designated as safety issue: No ]
nausea vomiting [ Time Frame: 48 postoperative hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 closed-loop administration using bispectral index as the single input for the controller.
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 dosage according to usual criteria

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772616

Locations

France
Hopital Foch
Suresnes, France, 92150

Sponsors and Collaborators

Hopital Foch

Investigators

Study Chair:

Marc Fischler, MD

Hopital Foch

More Information

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.

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.

Responsible Party:	Pr. Marc Fischler, Hopital Foch
ClinicalTrials.gov Identifier:	NCT00772616 History of Changes
Other Study ID Numbers:	2007/13
Study First Received:	October 11, 2008
Last Updated:	January 22, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:

Anesthesia
Analgesia
Patient-Controlled Analgesia
Hyperalgesia

Additional relevant MeSH terms:

Morphine
Remifentanil
Sufentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on June 18, 2013