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Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

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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

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE April 5, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Duration of mechanical ventilation [ Time Frame: 30 days after admitted to ICU ]
  • ICU length of stay [ Time Frame: 30 days after admitted to ICU ]
  • Psychomimetic adverse effects [ Time Frame: 72 hours after admitted to ICU ]
    incidence of delirium assess by CAM ICU hallucination nightmare
  • bowel motility [ Time Frame: 72 hours after admitted to ICU ]
    first pass stool day
  • 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
  • cardiovascular effect [ Time Frame: 72 hours after admitted to ICU ]
    Number of participants that experience tachyarrhythmia;- Supraventricular/ventricular tachycardia during ketamine infusion
  • 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
  • cardiovascular effect [ Time Frame: 72 hours after admitted to ICU ]
    Number of participants that experience sinus tachycardia rate >130 bpm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU
Official Title  ICMJE Efficacy of Ketamine-fentanyl VS Fentanyl for Analgosedation in Postoperative Ventilated SICU Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Critically Ill
  • Pain, Postoperative
Intervention  ICMJE
  • Drug: Ketamine
    ketamine in NSS (1 mg/ml) 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
Study Arms  ICMJE
  • Placebo Comparator: control
    0.9% NaCl IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr
    Intervention: Drug: Normal saline
  • Experimental: ketamine
    ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karuna Wongtangman, bechelor +66813475090 karuna.pha@gmail.com
Contact: Nuanprae Kitisin +66896767706 nkowenn@gmail.com
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03879564
Other Study ID Numbers  ICMJE Si783/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karuna Wongtangman, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mahidol University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP