Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Study Overview
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Brief Summary
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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.

Official Title
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Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial

Conditions
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Fracture, Dislocation

Intervention / Treatment
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* Drug: Procedural sedation with ketamine-propofol combination
* Drug: Procedural sedation with ketamine alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine-propofol<br> | Drug: Procedural sedation with ketamine-propofol combination<br>* 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).<br>|
| Active Comparator: Ketamine alone<br> | Drug: Procedural sedation with ketamine alone<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of recovery agitation | Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection | Recovery agitation is noted after procedural sedation for each patient (30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from first injection to optimal sedation |  | 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 | Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection | respiratory depression is assessed during procedural sedation for each patient (30 minutes) | 
| Proportion of arterial hypotension | Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection | Hypotension is assessed during procedural sedation for each patient (30 minutes) | 
| Proportion of vomiting | Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection | vomiting is assessed after procedural sedation for each patient (30 minutes) | 
| Recovery time | Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection | Recovery time is assessed after procedural sedation for each patient (30 minutes) | 
| Proportion of procedural failures | Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection | Procedural failure is noted for each patient if it's happened (30 minutes) | 
| Level of patient's satisfaction | Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection | after procedural sedation, patient's satisfaction is recorded (30 minutes) | 
| Level of care giver's satisfaction | Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection | after procedural sedation, care giver's satisfaction is recorded (30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procedural sedation, Ketamine-propofol, Ketamine