Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults

NCT01544725 | Completed Phase 4

• 1 other identifier: 11-PP-16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture; Dislocation

Keywords

Procedural sedation; Ketamine-propofol; Ketamine

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• 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)

• Proportion of respiratory depression

  respiratory depression is assessed during procedural sedation for each patient (30 minutes)

• Proportion of arterial hypotension

  Hypotension is assessed during procedural sedation for each patient (30 minutes)

• Proportion of vomiting

  vomiting is assessed after procedural sedation for each patient (30 minutes)

• Recovery time

  Recovery time is assessed after procedural sedation for each patient (30 minutes)

Study Arms (2)

Ketamine-propofol

EXPERIMENTAL

Drug: Procedural sedation with ketamine-propofol combination

Ketamine alone

ACTIVE COMPARATOR

Drug: Procedural sedation with ketamine alone

Interventions

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).

Ketamine alone

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).

Ketamine-propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• indication of procedural sedation

You may not qualify if:

• allergy to propofol or ketamine
• alcohol or drug intoxication
• altered mental status
• ASA physical status score \> 2
• hemodynamic unstability

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital St Roch

Nice, 06006, France

Location

Related Publications (1)

• Lemoel F, Contenti J, Giolito D, Boiffier M, Rapp J, Istria J, Fournier M, Ageron FX, Levraut J. Adverse Events With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial. Acad Emerg Med. 2017 Dec;24(12):1441-1449. doi: 10.1111/acem.13226. Epub 2017 Jul 14.

  PMID: 28493642 RESULT

MeSH Terms

Conditions

Fractures, Bone; Joint Dislocations

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fabien LEMOEL, MD

  CHU de Nice, FRANCE

  PRINCIPAL INVESTIGATOR

• Jacques LEVRAUT, PD, MD

  CHU de Nice, FRANCE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: March 6, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)