Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653520
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Maggie Jeffries, Avanti Anesthesia

Tracking Information
First Submitted Date  ICMJE August 23, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE June 28, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
Official Title  ICMJE Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description:
The surgeon was not aware which medication the patient received
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Drug: Diazepam
    5 or 10mg
  • Drug: Tramadol
    50mg or 100mg
  • Drug: Ondansetron
    1 or two tabs
  • Drug: MKO melt
    1 or 2 MKO melts
Study Arms  ICMJE
  • Active Comparator: diazepam only (group 1)
    Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation
    Intervention: Drug: Diazepam
  • Active Comparator: diazepam/tramadol/ondansetron (group 2)
    Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
    Interventions:
    • Drug: Diazepam
    • Drug: Tramadol
    • Drug: Ondansetron
  • Experimental: MKO only (group 3)
    Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation
    Intervention: Drug: MKO melt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
651
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 4, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03653520
Other Study ID Numbers  ICMJE ANES001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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.
Responsible Party Maggie Jeffries, Avanti Anesthesia
Study Sponsor  ICMJE Avanti Anesthesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maggie Jeffries, MD Avanti Anesthesia
PRS Account Avanti Anesthesia
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP