Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2027-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Descending Aortic Dissection Postoperative Pain Thoracoabdominal Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard of Care

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline infusion

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.

Group Type EXPERIMENTAL

Ketamine

Intervention Type 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.

Interventions

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Saline

Saline infusion

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* willing to give informed consent
* scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
* requires naloxone continuous infusion for spinal prophylaxis

Exclusion Criteria

* allergy to ketamine, acetaminophen, or fentanyl
* diagnosis of schizophrenia
* history of hydrocephalus or central nervous system mass
* incarcerated individuals
* pregnant or lactating individuals

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No