Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr
  • Normal saline (DRUG)
    NSS IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Condition or Disease

  • Critically Ill
  • Pain, Postoperative

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 124 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Apr 05, 2019 ACTUAL
    Primary Completion: May 01, 2020 ESTIMATED
    Completion Date: Jun 01, 2021 ESTIMATED
    Study First Posted: Mar 18, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 16, 2019

    Sponsors / Collaborators

    Lead Sponsor: Mahidol University
    Responsible Party: N/A

    Location

    Bangkok, Thailand
    Bangkok Noi, Bangkok, Thailand

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

    Secondary Outcomes
    • Duration of mechanical ventilation 30 days after admitted to ICU
    • ICU length of stay 30 days after admitted to ICU

    • incidence of delirium assess by CAM ICU hallucination nightmare

    • first pass stool day

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

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

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

    • Number of participants that experience sinus tachycardia rate \>130 bpm

    More Details

    NCT Number: NCT03879564
    Other IDs: Si783/2018
    Study URL: https://clinicaltrials.gov/study/NCT03879564
    Last updated: Sep 29, 2023