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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):

Study Description
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.


Condition or disease Intervention/treatment Phase
Fracture Dislocation Drug: Procedural sedation with ketamine-propofol combination Drug: Procedural sedation with ketamine alone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial
Study Start Date : April 2012
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ketamine-propofol 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).

Active Comparator: Ketamine alone 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).



Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544725


Locations
France
Hôpital St Roch
Nice, France, 06006
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Fabien LEMOEL, MD CHU de Nice, FRANCE
Study Director: Jacques LEVRAUT, PD, MD CHU de Nice, FRANCE
More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01544725     History of Changes
Other Study ID Numbers: 11-PP-16
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Centre Hospitalier Universitaire de Nice:
Procedural sedation
Ketamine-propofol
Ketamine

Additional relevant MeSH terms:
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action