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NCT03448068 · ClinicalTrials.gov registry record · Phase 2
Perioperative Ketamine for Pain With Gastric Bypass
A Phase 2 study of Ketamine and Laparoscopic Gastric Bypass Surgery, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03448068: Completed Phase 2 study of Ketamine and Laparoscopic Gastric Bypass Surgery, sponsored by Mayo Clinic.
NCT03448068 is a Phase 2 study of Ketamine and Laparoscopic Gastric Bypass Surgery that has completed, run by Mayo Clinic. The registered enrollment target is 34 participants, above the 31-participant average among 3 other Ketamine trials with a reported enrollment target (10% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03448068, a Phase 2 study of Ketamine and Laparoscopic Gastric Bypass Surgery, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea. Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients. This study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.
Primary Outcome
Measured in oral morphine equivalents
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG Standard therapy
Study Locations (1)
Arizona
- Mayo Clinic in Arizona - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-04-16 |
| Est. Completion | 2020-01-09 |
| Phase | Phase 2 |
What the finished NCT03448068 record still lists
NCT03448068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, above the 31-participant average among 3 other Ketamine trials with a reported enrollment target (10% higher).
The record links to 2 conditions, with Ketamine appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT03448068 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03448068 about?
NCT03448068 is a clinical study titled "Perioperative Ketamine for Pain With Gastric Bypass". Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apne...
What is the current status of trial NCT03448068?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2018-04-16. Estimated completion is 2020-01-09.
What conditions does trial NCT03448068 study?
This clinical trial studies the following conditions: Ketamine, Laparoscopic Gastric Bypass Surgery.
What interventions are being tested in trial NCT03448068?
The interventions under investigation include: Ketamine (DRUG), Standard therapy (DRUG).
Who is sponsoring clinical trial NCT03448068?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03448068 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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