Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
Phase: NA
Conditions: Cataract
Sponsor: Avanti Anesthesia

ANES001 IRB Application 
• 
Protocol Number 
o ANES 001 
• 
Protocol Date (Version #1) 
o 4/3/2017  
• 
Study Title 
o Effects of Various PO medication Combinations on Patient Satisfaction after 
Cataract Surgery 
• 
Sponsor Name  
 
o Maggie Jeffries, MD 
 
• 
Investigators (including sub-investigators) 
o Maggie Jeffries, MD – Primary Investigator 
o Secondary Investigators-  
§ 
Volker Eisele, MD 
§ 
Melinda Castrol, MD 
§ 
Edward Wade, MD 
§ 
Mark Mayo, MD 
§ 
Ciprian Georghe, MD, PhD – data collection and analysis 
• 
Address / Phone - Contact details 
o Maggie Jeffries 
o 2726 Bissonnet Ste 240-505, Houston, TX 77025 
o 832-390-4477 
• 
Source of external funding (if applicable) 
o Self funded 
• 
Hypothesis or Study Synopsis 
o We hypothesize that the combination of Valium, Tramadol and Zofran is 
superior to the substantially more expensive MKO melt in patient satisfaction 
after cataract surgery.  
• 
Background 
o The MKO melt is being pushed as the latest and greatest anesthetic medication 
for cataract surgery and has the advantage that it eliminates the need for an IV 
in 85% of patients.  This alternative, however, is very cost limiting.  
• 
Study Goals and Objectives 
o We wanted to see if our current regimen (valium only) or a combination similar 
to the MKO melt (valium + tramadol + zofran) are as good if not better than the 
MKO melt for anesthesia and how many patients could have indeed gone with 
an IV (didn’t need any extra medications). 
• 
Subject Selection  
o We plan to enroll 600 patients total.  200 patients in each of the 3 arms: 
§ 
Valium 10mg PO  
§ 
Tramadol 100mg PO, Valium 10mg PO, Zofran 4mg PO 

§ 
MKO melt x 2 SL (total of versed 6mg, ketamine 50mg, Zofran 4mg) 
o All patients scheduled for cataract surgery under Dr. Mayo and/or Dr. Wade will 
be enrolled on the day of surgery.  They will be randomized to which arm they 
are in by random envelopes. 
o Exclusion criteria: 
§ 
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 
• 
Study procedures / research method 
o Our participants will need to answer 2 questions before discharge from the 
PACU and answer 7 questions the following day when our nurse calls them.  
Currently, we already call all patients the day after surgery to see how things 
went so we will just have more specific questions.   
o We will be collecting the following information: 
§ 
Age 
§ 
Gender 
§ 
Ethnicity 
§ 
1st or 2nd eye 
§ 
Axial length 
§ 
ASA status 
§ 
Obesity 
§ 
OSA 
§ 
Number of allergies 
§ 
History of anxiety 
§ 
Current use of benzos   
§ 
Current use of narcotics  
 
§ 
Bradycardia <= 50 
§ 
ESRD/dialysis 
§ 
Times:  Meds received, laser time, surgical start and stop time 
§ 
IV Medications given (fentanyl, versed, brevital, other)– must be asked 
for my surgeon or patient only and reason documented (pain, anxiety, 
other) 
§ 
Difficulty of IV placement – number of tries, was it painful? 
§ 
Recovery survey –questionnaire for at discharge and during phone call 
the next day 
 
• 
Risk / Safety Information 
o There are no perceived risks to the participants 
• 
Monitoring and reporting of Adverse Events/Serious Adverse Events 
o The study doesn’t involve anything adding risk to the patient.  Risks of 
anesthesia are already present as we currently practice and all hospital transfers 
due to anesthesia are reportable events per state rules and regulations.  
• 
Study Oversight 

o Kirby Glen Surgery Center Governing body has approved the study and will 
provide oversight.  
• 
Data Management 
o Data will be managed by principal investigator Maggie Jeffries, MD into a 
database in her home office that is password protected.  
• 
IRB Review / Ethics / Informed Consent 
o The informed consent form has been submitted. This study also presents no 
additional risk to the patient outside of the anesthetic risk they would already 
have without the study.   
o No persons under the age of 18 will be enrolled in the study. No persons who 
cannot consent for themselves will be enrolled in the study.  No employees of 
our center will be enrolled in the study.  No persons who cannot read English 
will be enrolled in the study.  No persons with a terminal illness will be enrolled 
in the study.  
• 
Confidentiality 
o A patient sticker will be on the data collection sheet while the patient is in the 
center until the final phone call has taken place the day after surgery.  These 
sheets are kept at the surgery center in medical records at a fully HIPAA 
compliant surgery center.   
o Once data on a patient is complete on the data collection sheet, the patient 
sticker will be removed and placed in the shredder at the surgery center.   
o Data collection sheets will then be picked up weekly by Maggie Jeffries, MD and 
entered into the database at her home office.  The home computer where data 
will be kept is password protected and only used by Maggie Jeffries, MD.  These 
sheets which now contain no patient information, will be kept in a locked file 
cabinet until the completion of the study and publication is complete.  When 
appropriate, all sheets will also be shredded.  
o Access to the data will only be Maggie Jeffries, MD until data collection is 
complete and at that time, all investigators will have access to participate in 
preparing the data for publication.  
• 
Intended Use of Data 
o Our data can impact how anesthesia is performed for cataract surgery around 
the country.  This is one of the most common surgeries performed. 
o We plan on publishing our data in Anesthesia and/or Ophthalmology journal (s) 
as well as submit as poster presentations at Anesthesia and/or Ophthalmology 
national meetings.  No patient identifying information will be used as it is 
scrubbed from the data before data entry occurs (as above).   
 
 
 
 
 
 
____Maggie Jeffries MD_______________  
___4/3/17______ 

Signature of Investigator/Researcher                                      Date