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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: Diazepam; Drug: MKO melt; Drug: Tramadol; Drug: Ondansetron

• Registration Number: NCT03653520
• Lead Sponsor: Avanti Anesthesia

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 Timeline

• Study Start: 2017-06-28
• Primary Completion: 2017-11-02
• Study Completion: 2017-11-04
• Status Verified: 2018-08
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 651

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diazepam only (group 1)	Diazepam	Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation
MKO only (group 3)	MKO melt	Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation
diazepam/tramadol/ondansetron (group 2)	Tramadol	Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
diazepam/tramadol/ondansetron (group 2)	Diazepam	Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
diazepam/tramadol/ondansetron (group 2)	Ondansetron	Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation

Primary Outcome Measures

Name	Time	Method
Number of patient who needed additional IV medication for cataract surgery	1 day	Patients who require IV medications for self-reported pain or anxiety during surgery.

Trial Locations

Locations (1)

Memorial Hermann Kirby Glen Surgery Center; 🇺🇸 Houston, Texas, United States