Ketamine Sedation in Mechanically Ventilated Patients

NCT00122759 | Unknown

• 1 other identifier: LMR3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Pain; Psychomotor Agitation

Keywords

Mechanical ventilation; Agitation

Outcome Measures

Primary Outcomes (2)

• Comparison of the adequacy of sedation in patients receiving benzodiazepine plus opiate or this combination plus adjunctive ketamine

• Comparison of the cost of sedation with both regimens

Secondary Outcomes (2)

• Overall duration of mechanical ventilation

• Need to administer neuromuscular blocking agents

Interventions

ketamine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Pregnancy
• Patient who already receives neuromuscular blocking agents

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Réanimation Médicale, Hôpital Louis Mourier

Colombes, 92700, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 10816184 BACKGROUND

• 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.

  PMID: 10732935 BACKGROUND

• 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.

  PMID: 15891344 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Pain; Psychomotor Agitation

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jean-Damien Ricard, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didier D Dreyfuss, MD

CONTACT

33 1 47 60 61 93; didier.dreyfuss@lmr.ap-hop-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Start: December 1, 2005
• Study Completion: September 1, 2007
• Last Updated: July 23, 2007

Record last verified: 2007-07

Locations

FR (1)