Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
1 other identifier
interventional
651
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2017
CompletedFirst Submitted
Initial submission to the registry
August 23, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedAugust 31, 2018
August 1, 2018
4 months
August 23, 2018
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patient who needed additional IV medication for cataract surgery
Patients who require IV medications for self-reported pain or anxiety during surgery.
1 day
Study Arms (3)
diazepam only (group 1)
ACTIVE COMPARATORPatients are given 5 or 10mg of diazepam for sedation before surgery for sedation
diazepam/tramadol/ondansetron (group 2)
ACTIVE COMPARATORPatients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
MKO only (group 3)
EXPERIMENTALPatients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation
Interventions
Eligibility Criteria
You may qualify if:
- All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Hermann Kirby Glen Surgery Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maggie Jeffries, MD
Avanti Anesthesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- The surgeon was not aware which medication the patient received
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 23, 2018
First Posted
August 31, 2018
Study Start
June 28, 2017
Primary Completion
November 2, 2017
Study Completion
November 4, 2017
Last Updated
August 31, 2018
Record last verified: 2018-08