Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Avanti Anesthesia

Status: Completed

Conditions: Cataract

Treatments: Drug: Tramadol; Drug: MKO melt; Drug: Ondansetron; Drug: Diazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT03653520

ANES001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 651 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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651 participants in 3 patient groups

diazepam only (group 1)

Active Comparator group

Description:

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

Treatment:

Drug: Diazepam

diazepam/tramadol/ondansetron (group 2)

Active Comparator group

Description:

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

Treatment:

Drug: Tramadol

Drug: Ondansetron

Drug: Diazepam

MKO only (group 3)

Experimental group

Description:

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

Treatment:

Drug: MKO melt