Pain Clinical Trial
Official title:
Prospective Study on the Cost-Effectiveness of Adding Ketamine to Midazolam-Sufentanil Sedation Regimen in Mechanically Ventilated Patients
- Adequate sedation is of paramount importance to avoid stress and pain in mechanically
ventilated patients. It is usually achieved by infusing sedatives (benzodiazepine) and
analgesic (opiate) drugs.
- This combined sedation may not be sufficient in some instances.
- The aim of this study is to evaluate whether addition of a third substance, ketamine,
allows the achievement of better sedation and avoids the use of neuromuscular blocking
agents.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Mechanically ventilated patients who receive adequate dosing of sedative agents (midazolam > 0.15 mg/kg/h plus sufentanil > 0.3 mcg/kg/h) - Persistence of agitation indicating that sedation is not appropriate, as assessed by validated sedation scales (Harris scare; Motor Activity Assessment scale). Exclusion Criteria: - Pregnancy - Patient who already receives neuromuscular blocking agents |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Service de Réanimation Médicale, Hôpital Louis Mourier | Colombes |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Bourgoin A, Albanèse J, Léone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13. — View Citation
Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. — View Citation
Ostermann ME, Keenan SP, Seiferling RA, Sibbald WJ. Sedation in the intensive care unit: a systematic review. JAMA. 2000 Mar 15;283(11):1451-9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the adequacy of sedation in patients receiving benzodiazepine plus opiate or this combination plus adjunctive ketamine | |||
Primary | Comparison of the cost of sedation with both regimens | |||
Secondary | Overall duration of mechanical ventilation | |||
Secondary | Need to administer neuromuscular blocking agents |
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