Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults
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| ClinicalTrials.gov Identifier: NCT01544725 |
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Recruitment Status :
Completed
First Posted : March 6, 2012
Last Update Posted : December 1, 2016
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Fracture Dislocation | Drug: Procedural sedation with ketamine-propofol combination Drug: Procedural sedation with ketamine alone | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial |
| Study Start Date : | April 2012 |
| Actual Primary Completion Date : | January 2016 |
| Actual Study Completion Date : | January 2016 |
| Arm | Intervention/treatment |
|---|---|
| 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). |
- 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
- 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) ]
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544725
| France | |
| Hôpital St Roch | |
| Nice, France, 06006 | |
| Principal Investigator: | Fabien LEMOEL, MD | CHU de Nice, FRANCE | |
| Study Director: | Jacques LEVRAUT, PD, MD | CHU de Nice, FRANCE |
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01544725 |
| Other Study ID Numbers: |
11-PP-16 |
| First Posted: | March 6, 2012 Key Record Dates |
| Last Update Posted: | December 1, 2016 |
| Last Verified: | November 2016 |
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Procedural sedation Ketamine-propofol Ketamine |
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Joint Dislocations Joint Diseases Musculoskeletal Diseases Wounds and Injuries Ketamine Propofol Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous |
Anesthetics, General Anesthetics Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Dissociative Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |