Dislocation, Fracture
Conditions
Keywords
Procedural sedation, Ketamine-propofol, Ketamine
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.
Interventions
DRUGProcedural 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).
DRUGProcedural 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).
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of recovery agitation | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFabien LEMOEL, MD
CHU de Nice, FRANCE
STUDY_DIRECTORJacques LEVRAUT, PD, MD
CHU de Nice, FRANCE
Outcome results
None listed