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This study is designed to explore the sedative and analgesic effectiveness of the Midazolam/Ketamine melt compared to IV sedation in subjects undergoing intraocular surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract Surgery | Individuals undergoing cataract surgical intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam/Ketamine HCl 3mg-50mg sublingual | Drug | Single sublingual administration of Midazolam/Ketamine HCl 3mg-50mg sublingually prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Sedation | The Doctor/Nurse Anesthetist will evaluate the subject's level of sedation on the Ramsey Sedation Scale. Adequate sedation demonstrated by a score of 2 or higher on the Ramsey Scale:
The Ramsey scale is:
Source: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxolone-alphadalone. BMJ. 1974;2:656-659. | Duration of surgery |
| Level of Pain | Adequate pain control demonstrated by a score of 3 or below on the Numeric Pain Rating Scale (NPRS) by asking the following questions at the following times:
| Duration of surgery |
| Need for Rescue Medication | Percentage of patients requiring rescue medication (IV Fentanyl) for pain. Rescue medication will only be giving if a subject reports a pain level of 4 or higher on the NPRS. | Duration of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Eye Movement During Surgery | Eye movement during surgery (evaluated by a masked evaluator by reviewing operative recording). | Duration of surgery |
| Clinician's Global Impression | Clinician's impression of patient's sedation during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure changes | Blood pressure will be tracked at 3-5 minute intervals throughout the surgery. Any changes in blood pressure >20mmHg in systolic or diastolic will be identified as a clinically meaningful change. | Duration of surgery |
| Heart rate changes |
Inclusion Criteria:
Exclusion Criteria:
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Subjects requiring cataract removal
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| Name | Affiliation | Role |
|---|---|---|
| John Berdahl, MD | Vance Thompson Vision Clinic Prof. LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision Clinic | Sioux Falls | South Dakota | 57108 | United States | ||
| Vance Thompson Vision |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D007649 | Ketamine |
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Intravenous Sedatives with or Without Analgesia | Drug | Standard of Care |
|
|
| Duration of surgery |
| Patient Satisfaction | Patient satisfactions, determined by asking the patient "How satisfied were you with your overall experience?" at the one-day post-op or via phone call one-day post-op. | 1 day post operatively |
Heart rate will be tracked at 3-5 minute intervals throughout the surgery. Any changes in heart rates greater than 100 beats per minute or less than 60 beats per minute will be identified as a clinically meaningful change. |
| Duration of surgery |
| Sioux Falls |
| South Dakota |
| 57108 |
| United States |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000760 | Anesthesia and Analgesia |