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

• ClinicalTrials.gov Identifier: NCT03653520
• Recruitment Status: Completed
• First Posted: August 31, 2018
• Last Update Posted: August 31, 2018
• Sponsor: Avanti Anesthesia
• Information provided by (Responsible Party): Maggie Jeffries, Avanti Anesthesia

Tracking Information

• First Submitted Date: August 23, 2018
• First Posted Date: August 31, 2018
• Last Update Posted Date: August 31, 2018
• Actual Study Start Date: June 28, 2017
• Actual Primary Completion Date: November 2, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Cataract

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 28, 2018): 651
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 4, 2017
• Actual Primary Completion Date: November 2, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03653520
• Other Study ID Numbers: 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

• 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.

• Current Responsible Party: Maggie Jeffries, Avanti Anesthesia
• Original Responsible Party: Same as current
• Current Study Sponsor: Avanti Anesthesia
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Maggie Jeffries, MD; Avanti Anesthesia

• PRS Account: Avanti Anesthesia
• Verification Date: August 2018