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Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

ConditionsDescending Aortic DissectionPostoperative PainThoracoabdominal Aortic Aneurysm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSam Tyagi

About this trial

The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

willing to give informed consent

scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair

requires naloxone continuous infusion for spinal prophylaxis

Disqualifiers

allergy to ketamine, acetaminophen, or fentanyl

diagnosis of schizophrenia

history of hydrocephalus or central nervous system mass

incarcerated individuals

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline

    Drug

    Saline infusion

  • Ketamine

    Drug

    Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Standard of CarePlacebo comparator 1 intervention
Group B: Sub-Dissociative KetamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative Opioid Dose

Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.

Time frame
48 hours

Secondary outcomes

1

Change in Pain

Pain will be assessed using a 10-Point Numerical Pain Scale (as part of standard of care) every hour for the first 24 hours and every two hours for the next 24 hours. Scores range from 0-10; higher scores indicated higher levels of pain.

Time frame
48 hours
2

Number of Patients with Ketamine-Induced Delirium

Ketamine-induced delirium will be monitored via the Confusion Assessment Method (CAM-ICU) survey every 8 hours for 48 hours. The CAM-ICU assesses four diagnostic features of delirium and the result is a binary (yes or no) determination.

Time frame
48 hours
3

Number of Patients with Uncontrolled Hypertension

Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sam Tyagi

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
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