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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 11, 2008

Last Updated Date

January 22, 2011

Start Date ^ICMJE

September 2008

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00772616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Anesthesia

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: 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

Intervention: Drug: Sufentanil

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00772616

Other Study ID Numbers ^ICMJE

2007/13

Has Data Monitoring Committee

Responsible Party

Pr. Marc Fischler, Hopital Foch

Study Sponsor ^ICMJE

Hopital Foch

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Marc Fischler, MD

Hopital Foch

Information Provided By

Hopital Foch

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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