Vital SignsMAKERNCT04725747
Exploring Sedation Types During Cataract Surgery
An observational study of Vital Signs, run by Vance Thompson Vision at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Vital Signs
- What is being tested?
- Midazolam/Ketamine HCl 3mg-50mg sublingual and Intravenous Sedatives with or Without Analgesia
- Type of treatment
- Injection or infusion
- How many people
- 1,111 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects requiring cataract removal
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, 57108
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: A Retrospective Study Exploring Midazolam/Ketamine Melt vs IV Sedation in Subjects Undergoing Intraocular Surgery
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.
Read the 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.
- Conditions
- Vital Signs
- Being tested
- Midazolam/Ketamine HCl 3mg-50mg sublingual, Intravenous Sedatives with or Without Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam/Ketamine HCl 3mg-50mg sublingualDrug
Single sublingual administration of Midazolam/Ketamine HCl 3mg-50mg sublingually prior to surgery
Intravenous Sedatives with or Without AnalgesiaDrug
Also called IV Sedation
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Cataract Surgery | Individuals undergoing cataract surgical intervention Receives: Drug: Midazolam/Ketamine HCl 3mg-50mg sublingual; Drug: Intravenous Sedatives with or Without Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Upon entering operative room (before being prepped and draped)
- Immediately post-op upon entering the PACU
The Ramsey scale is:
- Patient is anxious and agitated or restless, or both
- Patient is co-operative, oriented, and tranquil
- Patient responds to commands only
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
- Patient exhibits no response
Source: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxolone-alphadalone. BMJ. 1974;2:656-659.
Measured: 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:
- "How painful was that on a scale of 0=no pain to 10=extreme pain?" will be asked:
- Upon insertion of the speculum
- Upon first incision
- Upon insertion of phacoemulsification probe
- Upon Lens insertion
- Upon removal of sterile drape
- "How would you rate your worst pain during surgery on a scale of 0=no pain to 10=extreme pain?" will be asked:
- Immediately after surgery in the OR
- 10-15 mins after the subject reaches the PACU
- "On a scale of 0=no pain to 10=extreme pain what number best describes your overall pain during the surgery?" Will be asked:
- Immediately after surgery in the OR
- 10-15 mins after the subject reaches the PACU
Measured: 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.
Measured: Duration of surgery
Secondary outcomes (3)
Eye Movement During Surgery
Eye movement during surgery (evaluated by a masked evaluator by reviewing operative recording).
Measured: Duration of surgery
Clinician's Global Impression
Clinician's impression of patient's sedation during surgery
Measured: 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.
Measured: 1 day post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start25 Jan 2021
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Berdahl, MD, Vance Thompson Vision
- Investigators
- John Berdahl, MD, Principal investigator, Vance Thompson Vision Clinic Prof. LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725747
- Sponsor's protocol ID
- MAKER
- Acronym
- MAKER
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Exploring Midazolam/Ketamine Melt vs IV Sedation in Subjects Undergoing Intraocular Surgery
- ClinicalTrials.gov ID
- NCT04725747
- Acronym / sponsor ID
- MAKER / MAKER
- Conditions
- Vital Signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract Surgery | – | Drug: Midazolam/Ketamine HCl 3mg-50mg sublingual, Drug: Intravenous Sedatives with or Without AnalgesiaIndividuals undergoing cataract surgical intervention |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects requiring cataract removal
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam/Ketamine HCl 3mg-50mg sublingualSingle sublingual administration of Midazolam/Ketamine HCl 3mg-50mg sublingually prior to surgery | Drug | Cataract Surgery |
| Intravenous Sedatives with or Without AnalgesiaAlso: IV SedationStandard of Care | Drug | Cataract Surgery |
Primary outcome
Level of Sedation
Time frame: Duration of surgery
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: * Upon entering operative room (before being prepped and draped) * Immediately post-op upon entering the PACU The Ramsey scale is: 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response Source: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxolone-alphadalone. BMJ. 1974;2:656-659.
Level of Pain
Time frame: Duration of surgery
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: 1. "How painful was that on a scale of 0=no pain to 10=extreme pain?" will be asked: * Upon insertion of the speculum * Upon first incision * Upon insertion of phacoemulsification probe * Upon Lens insertion * Upon removal of sterile drape 2. "How would you rate your worst pain during surgery on a scale of 0=no pain to 10=extreme pain?" will be asked: * Immediately after surgery in the OR * 10-15 mins after the subject reaches the PACU 3. "On a scale of 0=no pain to 10=extreme pain what number best describes your overall pain during the surgery?" Will be asked: * Immediately after surgery in the OR * 10-15 mins after the subject reaches the PACU
Need for Rescue Medication
Time frame: Duration of surgery
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.
3 secondary outcomes
Eye Movement During Surgery
Time frame: Duration of surgery
Clinician's Global Impression
Time frame: Duration of surgery
Patient Satisfaction
Time frame: 1 day post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Berdahl, MD principal investigator
Vance Thompson Vision Clinic Prof. LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs, run by Vance Thompson Vision at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Sedation (time frame: Duration of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.