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Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

Primary Purpose

Critically Ill, Pain, Postoperative

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Ketamine

Normal saline

About this trial

This is an interventional treatment trial for Critically Ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Older than 18 years.
Need ICU care
Need continuous iv fentanyl as an sedative of analgesia drug

Exclusion Criteria:

Pregnant women
Known allergy to ketamine
Severe cardiovascular disorders (ejection fraction< 30%, acute myocardial infarction, decompensated heart failure, significant tachyarrhythmia)
Acute psychosis
coma patient
receive
Renal insufficiency (creatinine clearance < 30 mL/min)
Unable to assess pain with either NRS or CPOT
Neurosurgery/ CVT patients/ trauma patients

Sites / Locations

Faculty of medicine Siriraj hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control

ketamine

Arm Description

0.9% NaCl IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Outcomes

Primary Outcome Measures

fentanyl consumption

the amount of fentanyl in microgram/kg in the patients who receive ketamine compare with who receive NSS

Secondary Outcome Measures

Duration of mechanical ventilation

ICU length of stay

Psychomimetic adverse effects

incidence of delirium assess by CAM ICU hallucination nightmare

bowel motility

first pass stool day

cardiovascular effect

Number of participants that experience episode of unexplained hypertension (sustained (> 30 min) increase in MAP + 25% from baseline) during ketamine infusion

cardiovascular effect

Number of participants that experience tachyarrhythmia;- Supraventricular/ventricular tachycardia during ketamine infusion

cardiovascular effect

Number of participants that experience atrial fibrillation with rapid ventricular response, rate > 110 bpm during ketamine infusion

cardiovascular effect

Number of participants that experience sinus tachycardia rate >130 bpm

Full Information

NCT ID

NCT03879564

First Posted

March 11, 2019

Last Updated

July 16, 2019

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT03879564

Brief Title

Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

Official Title

Efficacy of Ketamine-fentanyl VS Fentanyl for Analgosedation in Postoperative Ventilated SICU Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 5, 2019 (Actual)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blinded study to evaluate the analgosedative effect of ketamine in a surgical intensive care unit. The patients who will receive continuous fentanyl infusion for either pain control or sedation will be recruited in this trial. Fentanyl will be titrated with initial loading doses of 20 mcg until the numeral rating scale(NRS) less than 4 or critical care pain observation tool (CPOT) less than 3 or Richmond agitation sedation score (RASS) -2-0. Then the patients will be randomised in to receive saline infusion in control group (Group C) or ketamine infusion in ketamine group (Group K). Ketamine will be administered with an initial bolus of 0.3 mg/kg followed by a perfusion of1.5 mcg/kg/min during the first 48 h. The dose of fentanyl will be protocolized adjusted according to NRS or CPOT or RASS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critically Ill, Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

ketamine and normal saline will be filled in 50-ml syringe and will be administered in the same condition

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

0.9% NaCl IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Arm Title

ketamine

Arm Type

Experimental

Arm Description

ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

NSS IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Primary Outcome Measure Information:

Title

fentanyl consumption

Description

the amount of fentanyl in microgram/kg in the patients who receive ketamine compare with who receive NSS

Time Frame

48 hours after initial fentanyl infusion

Secondary Outcome Measure Information:

Title

Duration of mechanical ventilation

Time Frame

30 days after admitted to ICU

Title

ICU length of stay

Time Frame

30 days after admitted to ICU

Title

Psychomimetic adverse effects

Description

incidence of delirium assess by CAM ICU hallucination nightmare

Time Frame