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Completed

NCT Number: NCT01544725

Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

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.

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Key information

Conditions

Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital St Roch

Nice, 06006, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2012
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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