Trial | NCT03653520  Report issue

Title

Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    651
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.
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 Started
Jun 28
2017
Primary Completion
Nov 02
2017
Study Completion
Nov 04
2017
Last Update
Aug 31
2018

Drug Diazepam

5 or 10mg

Drug Tramadol

50mg or 100mg

Drug Ondansetron

1 or two tabs

Drug MKO melt [midazolam (versed), ketamine (ketalar), ondansetron (zofran)]

1 or 2 MKO melts

diazepam only (group 1) Active Comparator

Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation

diazepam/tramadol/ondansetron (group 2) Active Comparator

Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation

MKO only (group 3) Experimental

Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation

Criteria 

Inclusion Criteria:

All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center

Exclusion Criteria:

Age <18 years
Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness
Allergy to a medication in protocol
No Results Posted