Ketamine Sedation in Mechanically Ventilated Patients

NCT ID: NCT00122759

Last Updated: 2007-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-09-30

Brief Summary

• 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.

Detailed Description

• Mechanical ventilation is widely used in critically ill patients. Sedation is used in most instances to alleviate symptoms of pain and distress. It usually consists of an association of opiates and benzodiazepines.
• In some instances, pain and agitation persist despite this combined sedation regimen. In such cases, the clinicians have the choice between increasing dosage of these 2 substances which may increase their adverse effects (mainly hypotension) and/or adding a neuromuscular blocking agent which is not devoid of adverse effects (mainly the onset of neuromyopathy of critical illness).
• This study will assess the safety, efficacy and cost-effectiveness of adding ketamine, a well known anesthetic agent, to a combination of midazolam and sufentanil when this combination is not sufficient to reach acceptable sedation target.

Conditions

Respiratory Insufficiency; Pain; Psychomotor Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ketamine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Principal Investigators

Jean-Damien Ricard, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de Réanimation Médicale, Hôpital Louis Mourier

Colombes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Didier D Dreyfuss, MD

Role: CONTACT

didier.dreyfuss@lmr.ap-hop-paris.fr

33 1 47 60 61 93

Facility Contacts

Didier D Dreyfuss, MD

Role: primary

didier.dreyfuss@lmr.aphp.fr

33 147 60 6193

References

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. doi: 10.1056/NEJM200005183422002.

Reference Type: BACKGROUND

PMID: 10816184 (View on PubMed)

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. doi: 10.1001/jama.283.11.1451.

Reference Type: BACKGROUND

PMID: 10732935 (View on PubMed)

Bourgoin A, Albanese J, Leone 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. doi: 10.1097/01.ccm.0000162491.26292.98.

Reference Type: BACKGROUND

PMID: 15891344 (View on PubMed)

Other Identifiers

LMR3

Identifier Type: -

Identifier Source: org_study_id