Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01544725
First received: February 6, 2012
Last updated: July 24, 2014
Last verified: July 2014
  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:


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: July 2015
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).


  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 24, 2014
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
Wounds and Injuries
Ketamine
Propofol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on October 19, 2014