Status:
UNKNOWN
A Randomized, Double-Masked, Controlled, Single Site Investigator Initiated, Exploratory Study of the Midazolam/Ketamine Melt vs Ketamine Melt Alone vs Midazolam Melt Alone in Subjects Undergoing Intraocular Surgery.
Lead Sponsor:
Vance Thompson Vision
Conditions:
Anesthesia
Eligibility:
All Genders
55-80 years
Phase:
PHASE4
Brief Summary
This study is designed to explore the sedative and analgesic effectiveness of the Midazolam/Ketamine melt compared to Midazolam melt alone or Ketamine melt alone in subjects undergoing intraocular sur...
Detailed Description
Cataract surgery today is a highly effective and efficient procedure, with average times for completion ranging around 15 minutes in duration. Patients undergoing cataract surgery are typically given ...
Eligibility Criteria
Inclusion
- Subjects must be male or female, and between the ages of 55-80 years old.
- Subjects willing and able to sign the informed consent and capable of committing to the duration of the study.
- Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine.
- Subjects that are willing to have an IV placed prior to intraocular surgery
- Subjects undergoing first eye cataract surgery
- Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt.
Exclusion
- Subjects who have undergone sedation in the past 90 days.
- Women who are pregnant or lactating at the time of the study.
- Subjects who do not wish to or cannot comply with study procedures.
- Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results.
- Subjects with history of substance abuse.
- Subjects that are currently taking a prescription pain medication.
- Subjects that are not willing to abstain from all over-the-counter pain medication with the exception of 500-1000mg acetaminophen for 24 hours prior to surgery.
- Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery.
- Subjects with planned use of femtosecond laser, zepto, iris hooks or a malyugin ring during cataract surgery.
- Subjects with chronic pain rated moderate to severe within the past week.
- Subjects that have a psychiatric disorder that is currently uncontrolled.
- Subjects scheduled for same day bilateral or second eye cataract surgery.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04725747
Start Date
January 25 2021
End Date
June 30 2021
Last Update
January 27 2021
Active Locations (1)
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1
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108