Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544725
• Other study ID #: 11-PP-16
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2012
• Last updated: November 30, 2016
• Start date: April 2012
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocation
• Dislocations
• Fracture

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	Hôpital St Roch	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No