Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

Ketamine

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.

Intervention / Treatment

  • Procedural sedation with ketamine-propofol combination (DRUG)
    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 (DRUG)
    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).

Condition or Disease

  • Fracture
  • Dislocation

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 150 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2012
    Primary Completion: Jan 01, 2016 ACTUAL
    Completion Date: Jan 01, 2016 ACTUAL
    Study First Posted: Mar 06, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 30, 2016

    Sponsors / Collaborators

    Lead Sponsor: Centre Hospitalier Universitaire de Nice
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Nice, Provence-Alpes-Côte d'Azur, France

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

    Secondary Outcomes
    • 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)

    • Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

    • Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

    • Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection

    • Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection

    • Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection

    • Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

    • Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection

    More Details

    NCT Number: NCT01544725
    Other IDs: 11-PP-16
    Study URL: https://clinicaltrials.gov/study/NCT01544725
    Last updated: Sep 29, 2023