Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults - Full Text View

Purpose

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.

Condition	Intervention	Phase
Fracture Dislocation	Drug: Procedural sedation with ketamine-propofol combination Drug: Procedural sedation with ketamine alone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Depression Dislocations Fractures Low Blood Pressure Shoulder Injuries and Disorders

Drug Information available for: Ketamine hydrochloride Propofol Ketamine

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

Proportion of recovery agitation [ Time Frame: Recovery agitation is noted after procedural sedation for each patient (30 minutes) ] [ Designated as safety issue: No ]
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

Secondary Outcome Measures:

Time from first injection to optimal sedation [ Time Frame: Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection (30 minutes) ] [ Designated as safety issue: No ]
Proportion of respiratory depression [ Time Frame: respiratory depression is assessed during procedural sedation for each patient (30 minutes) ] [ Designated as safety issue: Yes ]
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Proportion of arterial hypotension [ Time Frame: Hypotension is assessed during procedural sedation for each patient (30 minutes) ] [ Designated as safety issue: Yes ]
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Proportion of vomiting [ Time Frame: vomiting is assessed after procedural sedation for each patient (30 minutes) ] [ Designated as safety issue: No ]
Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
Recovery time [ Time Frame: Recovery time is assessed after procedural sedation for each patient (30 minutes) ] [ Designated as safety issue: No ]
Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
Proportion of procedural failures [ Time Frame: Procedural failure is noted for each patient if it's happened (30 minutes) ] [ Designated as safety issue: No ]
Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
Level of patient's satisfaction [ Time Frame: after procedural sedation, patient's satisfaction is recorded (30 minutes) ] [ Designated as safety issue: No ]
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 [ Time Frame: after procedural sedation, care giver's satisfaction is recorded (30 minutes) ] [ Designated as safety issue: No ]
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

Estimated Enrollment:	150
Study Start Date:	April 2012
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

Arms

Assigned Interventions

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544725

Contacts

Contact: Delphine DEL CONT, MD

delcont.d@chu-nice.fr

Locations

France
Hôpital St Roch	Recruiting
Nice, France, 06006

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT01544725 History of Changes
Other Study ID Numbers:	11-PP-16
Study First Received:	February 6, 2012
Last Updated:	April 30, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Hospitalier Universitaire de Nice:

Procedural sedation
Ketamine-propofol
Ketamine

Additional relevant MeSH terms:

Dislocations
Fractures, Bone
Wounds and Injuries
Ketamine
Propofol
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013