Clinical trial NCT04725747: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 treatment arms. Arm 1 Ketamine/Midazolam melt. Arm 2 Ketamine melt. Arm 3 Midazolam melt.
Primary purpose: TREATMENT

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 surgery.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be male or female, and between the ages of 55-80 years old.
2. Subjects willing and able to sign the informed consent and capable of committing to the duration of the study.
3. Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine.
4. Subjects that are willing to have an IV placed prior to intraocular surgery
5. Subjects undergoing first eye cataract surgery
6. Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt.

Exclusion Criteria:

1. Subjects who have undergone sedation in the past 90 days.
2. Women who are pregnant or lactating at the time of the study.
3. Subjects who do not wish to or cannot comply with study procedures.
4. Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results.
5. Subjects with history of substance abuse.
6. Subjects that are currently taking a prescription pain medication.
7. 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.
8. Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery.
9. Subjects with planned use of femtosecond laser, zepto, iris hooks or a malyugin ring during cataract surgery.
10. Subjects with chronic pain rated moderate to severe within the past week.
11. Subjects that have a psychiatric disorder that is currently uncontrolled.
12. Subjects scheduled for same day bilateral or second eye cataract surgery.

Primary outcomes:
measure: Level of Sedation
timeFrame: Duration of surgery
measure: Level of Pain
timeFrame: Duration of surgery
measure: Need for Rescue Medication
timeFrame: Duration of surgery
Secondary outcomes:
measure: Eye Movement During Surgery
timeFrame: Duration of surgery
measure: Clinician's Global Impression
timeFrame: Duration of surgery
measure: Patient Satisfaction
timeFrame: 1 day post operatively
Other outcomes:
measure: Blood pressure changes
timeFrame: Duration of surgery
measure: Heart rate changes
timeFrame: Duration of surgery
Locations:
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
References: