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OpenTrials
Completed

NCT Number: NCT03653520

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Kirby Glen Surgery Center

Houston, Texas, 77030, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazepam

Drug

5 or 10mg

Tramadol

Drug

50mg or 100mg

ondansetron

Drug

1 or two tabs

MKO melt

Drug

1 or 2 MKO melts

Primary outcomes

  1. Number of patient who needed additional IV medication for cataract surgery

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Avanti Anesthesia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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