Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03653520
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
Sponsor:
Avanti Anesthesia
Organization:
Study Overview
Official Title:
Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.
Detailed Description:
The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: