Back to resultsConscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diazepam
Tramadol
Ondansetron
MKO melt
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility 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
Sites / Locations
- Memorial Hermann Kirby Glen Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
diazepam only (group 1)
diazepam/tramadol/ondansetron (group 2)
MKO only (group 3)
Arm Description
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
Outcomes
Primary Outcome Measures
Number of patient who needed additional IV medication for cataract surgery
Patients who require IV medications for self-reported pain or anxiety during surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03653520
Brief Title
Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
Official Title
Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
November 2, 2017 (Actual)
Study Completion Date
November 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Avanti Anesthesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
The surgeon was not aware which medication the patient received
Allocation
Randomized
Enrollment
651 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diazepam only (group 1)
Arm Type
Active Comparator
Arm Description
Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation
Arm Title
diazepam/tramadol/ondansetron (group 2)
Arm Type
Active Comparator
Arm 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
Arm Title
MKO only (group 3)
Arm Type
Experimental
Arm Description
Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation
Intervention Type
Drug
Intervention Name(s)
Diazepam
Intervention Description
5 or 10mg
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
50mg or 100mg
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
1 or two tabs
Intervention Type
Drug
Intervention Name(s)
MKO melt
Intervention Description
1 or 2 MKO melts
Primary Outcome Measure Information:
Title
Number of patient who needed additional IV medication for cataract surgery
Description
Patients who require IV medications for self-reported pain or anxiety during surgery.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie Jeffries, MD
Organizational Affiliation
Avanti Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Kirby Glen Surgery Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be available to those who contact primary investigator. We may decide to fully publish data but are undecided.
Learn more about this trial
Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
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