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Ketamine Sedation in Mechanically Ventilated Patients

Primary Purpose

Respiratory Insufficiency, Pain, Psychomotor Agitation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ketamine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Mechanical ventilation, Agitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Réanimation Médicale, Hôpital Louis MourierRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

Overall duration of mechanical ventilation
Need to administer neuromuscular blocking agents

Full Information

First Posted
July 19, 2005
Last Updated
July 20, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00122759
Brief Title
Ketamine Sedation in Mechanically Ventilated Patients
Official Title
Prospective Study on the Cost-Effectiveness of Adding Ketamine to Midazolam-Sufentanil Sedation Regimen in Mechanically Ventilated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Pain, Psychomotor Agitation
Keywords
Mechanical ventilation, Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ketamine
Primary Outcome Measure Information:
Title
Comparison of the adequacy of sedation in patients receiving benzodiazepine plus opiate or this combination plus adjunctive ketamine
Title
Comparison of the cost of sedation with both regimens
Secondary Outcome Measure Information:
Title
Overall duration of mechanical ventilation
Title
Need to administer neuromuscular blocking agents

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Didier D Dreyfuss, MD
Phone
33 1 47 60 61 93
Email
didier.dreyfuss@lmr.ap-hop-paris.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Damien Ricard, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation Médicale, Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier D Dreyfuss, MD
Phone
33 147 60 6193
Email
didier.dreyfuss@lmr.aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
10816184
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. doi: 10.1056/NEJM200005183422002.
Results Reference
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PubMed Identifier
10732935
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. doi: 10.1001/jama.283.11.1451.
Results Reference
background
PubMed Identifier
15891344
Citation
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.
Results Reference
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Ketamine Sedation in Mechanically Ventilated Patients

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