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NCT04220489 · ClinicalTrials.gov registry record · Phase 2
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
A Phase 2 study, sponsored by Jacques E. Chelly.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04220489 is a Phase 2 study that was terminated before completion, run by Jacques E. Chelly. The registered enrollment target is 1 participants.
The verdict
NCT04220489, a Phase 2 study, was terminated before completion, sponsored by Jacques E. Chelly.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when compared to placebo Opioid dependence will be defined as daily opioid use (2 or more doses per day) for a period of two-months or longer. Intraoperatively, patients will receive a 1 mg/kg dose of intravenous ketamine or saline with 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr or saline will be run to conclude at 24 hours after the end of the surgery (fascial closure). The primary outcome measure will be hydromorphone PCA usage during the first 72 hours postoperatively. Secondary outcome measures will be VAS pain scores at rest and with movement in PACU, 24 hr, 48 hr, 72 hr, 2 week (post-op visit), 6 week follow-up visit, as well as, McGill Pain Questionnaire, Pain Catastrophizing Scale, and emotional distress surveys assessing depression and anxiety at preop/screening, postop and 6 week follow-up (PROMIS Emotional Distress-Anxiety Short Form, PROMIS Emotional Distress-Depression Short Form), as well as a Neuro-QOL Short Form v1.1 - Satisfaction with Social Roles and Activities .
Interventions
- DRUG Ketamine
- DRUG Placebo Comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2022-11-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04220489
The ClinicalTrials.gov registry entry for NCT04220489 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jacques E. Chelly, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT04220489 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04220489 about?
NCT04220489 is a clinical study titled "Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery". The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when co...
What is the current status of trial NCT04220489?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-12-17. Estimated completion is 2022-11-19.
What interventions are being tested in trial NCT04220489?
The interventions under investigation include: Ketamine (DRUG), Placebo Comparator (DRUG).
Who is sponsoring clinical trial NCT04220489?
This trial is sponsored by Jacques E. Chelly, which has 10 total clinical trials registered on ClinicalTrials.gov.
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