Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Phase 4

Completed

• Conditions: Dislocation; Fracture
• Interventions: Drug: Procedural sedation with ketamine alone; Drug: Procedural sedation with ketamine-propofol combination

• Registration Number: NCT01544725
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 available

Study Timeline

• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-06
• Study Start: 2012-04
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine alone	Procedural sedation with ketamine alone	-
Ketamine-propofol	Procedural sedation with ketamine-propofol combination	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 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
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
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
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

Trial Locations

Locations (1)

Hôpital St Roch; 🇫🇷 Nice, France