Clinical trial NCT01544725: Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults
Official title: Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fracture
Dislocation
Keywords: Procedural sedation
Ketamine-propofol
Ketamine
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of recovery agitation
timeFrame: Recovery agitation is noted after procedural sedation for each patient (30 minutes)
Secondary outcomes:
measure: Time from first injection to optimal sedation
timeFrame: Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection (30 minutes)
measure: Proportion of respiratory depression
timeFrame: respiratory depression is assessed during procedural sedation for each patient (30 minutes)
measure: Proportion of arterial hypotension
timeFrame: Hypotension is assessed during procedural sedation for each patient (30 minutes)
measure: Proportion of vomiting
timeFrame: vomiting is assessed after procedural sedation for each patient (30 minutes)
measure: Recovery time
timeFrame: Recovery time is assessed after procedural sedation for each patient (30 minutes)
measure: Proportion of procedural failures
timeFrame: Procedural failure is noted for each patient if it's happened (30 minutes)
measure: Level of patient's satisfaction
timeFrame: after procedural sedation, patient's satisfaction is recorded (30 minutes)
measure: Level of care giver's satisfaction
timeFrame: after procedural sedation, care giver's satisfaction is recorded (30 minutes)
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital St Roch
Study officials:
affiliation: CHU de Nice, FRANCE
name: Fabien LEMOEL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Nice, FRANCE
name: Jacques LEVRAUT, PD, MD
role: STUDY_DIRECTOR
References: