Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Fracture; Dislocation
• Intervention / Treatment: Drug: Procedural sedation with ketamine-propofol combination; Drug: Procedural sedation with ketamine alone

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nice, France, 06006
    • Hôpital St Roch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (ESTIMATE): March 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Ketamine; Procedural sedation; Ketamine-propofol
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Propofol
• Other Study ID Numbers: 11-PP-16