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.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anesthesia
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 1:1:1 treatment arms. Arm 1 Ketamine/Midazolam melt. Arm 2 Ketamine melt. Arm 3 Midazolam melt.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: This is a double masked study in which the doctor/nurse anesthetist evaluating the subject with the Ramsey scale will be masked to the treatment given. The subject will also be masked to the treatment group and the study/control drug. To keep the doctor/nurse anesthetist masked, the unmasked nurse will prepare the study/control drug and then administer it to the subject without unmasking the doctor/nurse anesthetist or the subject. The unmasked nurse will administer one 3/50mg MK melt, or one 3mg Midazolam melt, or one 50mg Ketamine melt sublingually based on the subject's randomization assignment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 55 years and 80 years
- Gender
- Both males and females
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 sedatives and often times pain medication (e.g. opioids) just prior to and during the procedure. The...
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 sedatives and often times pain medication (e.g. opioids) just prior to and during the procedure. The overwhelming majority of patients are given these medications via intravenous administration. The insertion of an IV line has been associated with patient complaints of pain and bruising, and can increase the administrative burden on the clinical staff. In addition to the national crisis surrounding opioid abuse, opioids have many negative side effects during cataract surgery such as respiratory depression, dizziness, nausea, and post- operative vomiting. To reduce the side effects, improve patient satisfaction, and help surgical center flow the Midazolam/Ketamine melt (MK Melt) has been suggested as an alternative to provide sedation and analgesia in subjects undergoing minor outpatient surgery, such as cataract surgery. The addition of ketamine should provide enough analgesia for the mild discomfort reported during cataract surgery. This study is intended to evaluate the MK Melt and its ability to provide an adequate level of both sedation and intraoperative pain control vs an active control.
Tracking Information
- NCT #
- NCT04725747
- Collaborators
- Not Provided
- Investigators
- Not Provided
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