2020Ketamine: Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

Sponsor

Anna Rockich (Other)

Overall Status

Recruiting

CT.gov ID

NCT04600089

Collaborator

(none)

Enrollment

Location

Arms

31.7

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Descending Aortic Dissection Postoperative Pain Thoracoabdominal Aortic Aneurysm	Drug: Saline Drug: Ketamine	Phase 2

Detailed Description

Patients undergoing descending aortic repair often experience post-operative pain, and have high post operative opioid requirements. That pain is partially due to the use of naloxone continuous infusion (NCI). NCI is part of a bundled approach used in the first 48 hours post-operatively to prevent spinal cord ischemia, a devastating complication associated with surgical repair of the descending aortic. Data indicate that patients receiving NCI experience elevated post-operative pain scores and increased opioid requirements during the 48-hr post-operative NCI administration, compared to patients not receiving NCI.

Ketamine is an FDA-approved N-methyl D-aspartate (NMDA) antagonist that has been shown to provide adjunctive analgesia and opioid-sparing effects in post-operative surgical patients. At low doses, ketamine provides analgesic benefit without the anesthetic effects seen at higher doses. These doses are commonly referred to sub-dissociative. This study will evaluate whether use of sub dissociative ketamine (SDK) in patients undergoing aortic procedures with the use of NCI will lead to decreased post-operative opioid consumption, and produce improved pain scores in the first 48 hours.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Study to Identify the Opioid-sparing Effects, and Pain-reduction Potential of Low Dose Ketamine on Patients Undergoing TEVAR Procedures Receiving NCI

Actual Study Start Date :

Dec 8, 2020

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Standard of Care Participants in this group will receive standard of care as well as a saline infusion during the study period.	Drug: Saline Saline infusion
Experimental: Sub-Dissociative Ketamine Participants in this group will receive standard of care as well as a continuous ketamine infusion at the induction of anesthesia and for 48 hours postoperatively.	Drug: Ketamine Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.

Arm

Intervention/Treatment

Placebo Comparator: Standard of Care

Participants in this group will receive standard of care as well as a saline infusion during the study period.

Drug: Saline

Saline infusion

Experimental: Sub-Dissociative Ketamine

Participants in this group will receive standard of care as well as a continuous ketamine infusion at the induction of anesthesia and for 48 hours postoperatively.

Drug: Ketamine

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

Outcome Measures

Primary Outcome Measures

Cumulative Opioid Dose [48 hours]
Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.

Secondary Outcome Measures

Change in Pain [48 hours]
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.
Number of Patients with Ketamine-Induced Delirium [48 hours]
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.
Number of Patients with Uncontrolled Hypertension [48 hours]
Uncontrolled hypertension is defined as a systolic pressure of 160 mmHg despite 3 intravenous antihypertensive agents.