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History of Changes for Study: NCT01544725
Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults
Latest version (submitted November 30, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 29, 2012 None (earliest Version on record)
2 April 30, 2012 Recruitment Status, Study Status and Contacts/Locations
3 July 24, 2014 Study Status
4 September 29, 2015 Study Status
5 November 30, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT01544725
Submitted Date:  February 29, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 11-PP-16
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2012
Overall Status: Not yet recruiting
Study Start: March 2012
Primary Completion: March 2012 [Anticipated]
Study Completion: March 2014 [Anticipated]
First Submitted: February 6, 2012
First Submitted that
Met QC Criteria:
February 29, 2012
First Posted: March 6, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 29, 2012
Last Update Posted: March 6, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Centre Hospitalier Universitaire de Nice
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Fracture
Dislocation
Keywords: Procedural sedation
Ketamine-propofol
Ketamine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
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).

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of recovery agitation
[ Time Frame: 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:
1. 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) ]

2. Proportion of respiratory depression
[ Time Frame: 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
3. Proportion of arterial hypotension
[ Time Frame: 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
4. Proportion of vomiting
[ Time Frame: 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
5. Recovery time
[ Time Frame: 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
6. Proportion of procedural failures
[ Time Frame: 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
7. Level of patient's satisfaction
[ Time Frame: 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
8. Level of care giver's satisfaction
[ Time Frame: 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Delphine DEL CONT, MD
Email: delcont.d@chu-nice.fr
Study Officials: Fabien LEMOEL, MD
Principal Investigator
CHU de Nice, FRANCE
Jacques LEVRAUT, PD, MD
Study Director
CHU de Nice, FRANCE
Locations: France
Nice, France, 06006
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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