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Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03879564
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Karuna Wongtangman, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Critically Ill Pain, Postoperative Drug: Ketamine Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: ketamine and normal saline will be filled in 50-ml syringe and will be administered in the same condition
Primary Purpose: Treatment
Official Title: Efficacy of Ketamine-fentanyl VS Fentanyl for Analgosedation in Postoperative Ventilated SICU Patients
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: control
0.9% NaCl IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr
Drug: Normal saline
NSS IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

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




Primary Outcome Measures :
  1. fentanyl consumption [ Time Frame: 48 hours after initial fentanyl infusion ]
    the amount of fentanyl in microgram/kg in the patients who receive ketamine compare with who receive NSS


Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: 30 days after admitted to ICU ]
  2. ICU length of stay [ Time Frame: 30 days after admitted to ICU ]
  3. Psychomimetic adverse effects [ Time Frame: 72 hours after admitted to ICU ]
    incidence of delirium assess by CAM ICU hallucination nightmare

  4. bowel motility [ Time Frame: 72 hours after admitted to ICU ]
    first pass stool day

  5. cardiovascular effect [ Time Frame: 72 hours after admitted to ICU ]
    Number of participants that experience episode of unexplained hypertension (sustained (> 30 min) increase in MAP + 25% from baseline) during ketamine infusion

  6. cardiovascular effect [ Time Frame: 72 hours after admitted to ICU ]
    Number of participants that experience tachyarrhythmia;- Supraventricular/ventricular tachycardia during ketamine infusion

  7. cardiovascular effect [ Time Frame: 72 hours after admitted to ICU ]
    Number of participants that experience atrial fibrillation with rapid ventricular response, rate > 110 bpm during ketamine infusion

  8. cardiovascular effect [ Time Frame: 72 hours after admitted to ICU ]
    Number of participants that experience sinus tachycardia rate >130 bpm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03879564


Contacts
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Contact: Karuna Wongtangman, bechelor +66813475090 karuna.pha@gmail.com
Contact: Nuanprae Kitisin +66896767706 nkowenn@gmail.com

Locations
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Thailand
Faculty of medicine Siriraj hospital Recruiting
Bangkok Noi, Bangkok, Thailand, 10700
Contact: Karuna Wongtangman    024197879    karuna.pha@gmail.com   
Sponsors and Collaborators
Mahidol University

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Responsible Party: Karuna Wongtangman, principle investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03879564    
Other Study ID Numbers: Si783/2018
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Pain, Postoperative
Disease Attributes
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia