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

Ketamine

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.

Intervention / Treatment

  • Diazepam (DRUG)
    5 or 10mg
  • Tramadol (DRUG)
    50mg or 100mg
  • Ondansetron (DRUG)
    1 or two tabs
  • MKO melt (DRUG)
    1 or 2 MKO melts

Condition or Disease

  • Cataract

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 651 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    The surgeon was not aware which medication the patient received

    SINGLE:
    • Care Provider

    Clinical Trial Dates

    Start date: Jun 28, 2017 ACTUAL
    Primary Completion: Nov 02, 2017 ACTUAL
    Completion Date: Nov 04, 2017 ACTUAL
    Study First Posted: Aug 31, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 28, 2018

    Sponsors / Collaborators

    Lead Sponsor: Avanti Anesthesia
    Responsible Party: N/A

    Location

    Houston, Texas, USA

    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).

    Participant Groups

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

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Patients who require IV medications for self-reported pain or anxiety during surgery.

    More Details

    NCT Number: NCT03653520
    Other IDs: ANES001
    Study URL: https://clinicaltrials.gov/study/NCT03653520
    Last updated: Sep 29, 2023