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

Si783/2018

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. We tested the research hypothesis that low-doseketamine infusion is associated with a reduced fentanyl dose without increased vulnerability to its psychotropic effects.

2019-04-05

2021-12-30

2024-06-01

Active (not recruiting)

Early phase I

124

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'ketamine and normal saline will be filled in 50-ml syringe and will be administered in the same condition', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 124, 'type': 'ESTIMATED'}}

2023-11-21