Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00772616

Enrollment

Registered

2008-10-15

Start date

2008-09-30

Completion date

2011-01-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, Analgesia, Patient-Controlled Analgesia, Hyperalgesia

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.

Interventions

DRUGRemifentanil

closed-loop administration using bispectral index as the single input for the controller.

DRUGSufentanil

dosage according to usual criteria

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
nausea vomiting	48 postoperative hours
postoperative pain scores	48 postoperative hours
postoperative hyperalgesia	up to 5th to 7th postoperative days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026