Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

• ClinicalTrials.gov Identifier: NCT03879564
• Recruitment Status: Unknown
• First Posted: March 18, 2019
• Last Update Posted: July 18, 2019
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Karuna Wongtangman, Mahidol University

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Karuna Wongtangman, bechelor; +66813475090; karuna.pha@gmail.com

Contact: Nuanprae Kitisin; +66896767706; nkowenn@gmail.com

Locations

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

More Information

• Responsible Party: Karuna Wongtangman, principle investigator, Mahidol University
• ClinicalTrials.gov Identifier: NCT03879564
• Other Study ID Numbers: Si783/2018
• First Posted: March 18, 2019
• Last Update Posted: July 18, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Critical Illness; Pain, Postoperative; Disease Attributes; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; 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