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Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

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ClinicalTrials.gov Identifier: NCT01544725
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE March 6, 2012
Last Update Posted Date December 1, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2012)
Proportion of recovery agitation [ Time Frame: Recovery agitation is noted after procedural sedation for each patient (30 minutes) ]
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2012)
  • Time from first injection to optimal sedation [ Time Frame: Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection (30 minutes) ]
  • Proportion of respiratory depression [ Time Frame: respiratory depression is assessed during procedural sedation for each patient (30 minutes) ]
    Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
  • Proportion of arterial hypotension [ Time Frame: Hypotension is assessed during procedural sedation for each patient (30 minutes) ]
    Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
  • Proportion of vomiting [ Time Frame: vomiting is assessed after procedural sedation for each patient (30 minutes) ]
    Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
  • Recovery time [ Time Frame: Recovery time is assessed after procedural sedation for each patient (30 minutes) ]
    Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
  • Proportion of procedural failures [ Time Frame: Procedural failure is noted for each patient if it's happened (30 minutes) ]
    Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
  • Level of patient's satisfaction [ Time Frame: after procedural sedation, patient's satisfaction is recorded (30 minutes) ]
    Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
  • Level of care giver's satisfaction [ Time Frame: after procedural sedation, care giver's satisfaction is recorded (30 minutes) ]
    Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults
Official Title  ICMJE Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial
Brief Summary

Using Ketamine for procedural sedation in adults is often uncomfortable for emergency physicians because of the significant proportion of patients experimenting recovery agitation. The investigators believe that combining propofol to ketamine, the proportion of recovery agitation will be significantly lowered.

The objectives of this double-blinded, randomized controlled trial are to compare the proportion of recovery agitation in adults receiving procedural sedation with ketamine-propofol versus ketamine alone, and to compare the proportion of other classical procedural sedation side-effects and parameters such as respiratory depression, hypotension, sedation duration, time of recovery, procedural failures, and levels of satisfaction.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fracture
  • Dislocation
Intervention  ICMJE
  • Drug: Procedural sedation with ketamine-propofol combination

    K= Kétamine P= Propofol RSS= Ramsay Sedation Score

    At t0: 0.5 mg/kg of K (0.1 ml/kg of 5 mg/ml K) followed by 0.5 mg/k of P (0.1 ml/kg of 5 mg/ml P).

    At t0 + 4 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).

    At t0 + 8 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).

    At t0 + 12 min, if maximal doses have been reached (1 mg/kg of K + 1 mg/kg of P) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver).

  • Drug: Procedural sedation with ketamine alone

    K= Ketamine I= Intralipid placebo

    At t0: 1 mg/kg of K (0.1 ml/kg of 10 mg/ml K), followed by 0.1 ml/kg of I (physical placebo of propofol in the other arm).

    At t0 + 4 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.

    At t0 + 8 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.

    At t0 + 12 min, if maximal doses have been used (2 mg/kg of K) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver).

Study Arms  ICMJE
  • Experimental: Ketamine-propofol
    Intervention: Drug: Procedural sedation with ketamine-propofol combination
  • Active Comparator: Ketamine alone
    Intervention: Drug: Procedural sedation with ketamine alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2012)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years and older
  • indication of procedural sedation

Exclusion Criteria:

  • allergy to propofol or ketamine
  • alcohol or drug intoxication
  • altered mental status
  • ASA physical status score > 2
  • hemodynamic unstability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01544725
Other Study ID Numbers  ICMJE 11-PP-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fabien LEMOEL, MD CHU de Nice, FRANCE
Study Director: Jacques LEVRAUT, PD, MD CHU de Nice, FRANCE
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP