Use of Ketamine Associate With an Opioid for Sedation in ICU

Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01560390

Acronym

KetaRea

Enrollment

164

Registered

2012-03-22

Start date

2011-10-31

Completion date

2012-08-31

Last updated

2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation for Mechanical Ventilation

Keywords

Sedation, ICU, Ketamine, Confusion, Hyperalgesia

Brief summary

The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.

Detailed description

All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.

Interventions

DRUGRémifentamil + KETAMINE

All consecutive mechanically ventilated patients admitted in the ICU will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.

DRUGketamine

to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* all patients under mechanical ventilation

Exclusion criteria

* pregnant * psychotic * chronic use of opiates * age \< 18 years

Design outcomes

Primary

Measure	Time frame
Amount of opiate used between study enrollment and mechanical ventilation withdrawal.	after 24 hours

Secondary

Measure	Time frame
Confusion Duration assessed by CAM-ICU	after 24 hours
mechanical ventilation duration	after 24 hours
ICU length of stay	after 24 hours
Mortality at D28	at day 28
hyperalgesia during sedation	after 24 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026