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Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00772616
First received: October 11, 2008
Last updated: January 22, 2011
Last verified: January 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Remifentanil
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014