CataractNCT03653520
Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
A study testing Diazepam, Tramadol and Ondansetron in people with Cataract, run by Avanti Anesthesia at 1 site in United States.
Trial summary
The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Diazepam, Tramadol and Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 4 Nov 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Kirby Glen Surgery Center
Houston, Texas, 77030
About this study
Official title: Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.
Read the detailed description
The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the 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 intravenous line (didn't need any extra medications).
- Conditions
- Cataract
- Being tested
- Diazepam, Tramadol, Ondansetron, MKO melt
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
5 or 10mg
TramadolDrug
50mg or 100mg
OndansetronDrug
1 or two tabs
MKO meltDrug
1 or 2 MKO melts
| Study group | Role | What they receive |
|---|---|---|
| diazepam only (group 1) | Active comparator | Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation Receives: Drug: Diazepam |
| diazepam/tramadol/ondansetron (group 2) | Active comparator | Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation Receives: Drug: Diazepam; Drug: Tramadol; Drug: Ondansetron |
| MKO only (group 3) | Experimental | Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation Receives: Drug: MKO melt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient who needed additional IV medication for cataract surgery
Patients who require IV medications for self-reported pain or anxiety during surgery.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start28 Jun 2017
- Primary completion2 Nov 2017
- Study completion4 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanti Anesthesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maggie Jeffries, Avanti Anesthesia
- Investigators
- Maggie Jeffries, MD, Principal investigator, Avanti Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653520
- Sponsor's protocol ID
- ANES001
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data for all primary and secondary outcome measures will be available to those who contact primary investigator. We may decide to fully publish data but are undecided.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery
- ClinicalTrials.gov ID
- NCT03653520
- Acronym / sponsor ID
- ANES001
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Avanti AnesthesiaUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 4 Nov 2017 (actual)
- First posted
- 31 Aug 2018 (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.
The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.
Detailed description
The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the 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 intravenous line (didn't need any extra medications).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diazepam only (group 1) | Active comparator | Drug: DiazepamPatients are given 5 or 10mg of diazepam for sedation before surgery for sedation |
| diazepam/tramadol/ondansetron (group 2) | Active comparator | Drug: Diazepam, Drug: Tramadol, Drug: OndansetronPatients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation |
| MKO only (group 3) | Experimental | Drug: MKO meltPatients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Diazepam5 or 10mg | Drug | diazepam only (group 1), diazepam/tramadol/ondansetron (group 2) |
| Tramadol50mg or 100mg | Drug | diazepam/tramadol/ondansetron (group 2) |
| Ondansetron1 or two tabs | Drug | diazepam/tramadol/ondansetron (group 2) |
| MKO melt1 or 2 MKO melts | Drug | MKO only (group 3) |
Primary outcome
Number of patient who needed additional IV medication for cataract surgery
Time frame: 1 day
Patients who require IV medications for self-reported pain or anxiety during surgery.
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 31 Aug 2018.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data for all primary and secondary outcome measures will be available to those who contact primary investigator. We may decide to fully publish data but are undecided.
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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.
Maggie Jeffries, MD principal investigator
Avanti Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diazepam, Tramadol and Ondansetron in people with Cataract, run by Avanti Anesthesia at 1 site 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 1 inclusion and 3 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of patient who needed additional IV medication for cataract surgery (time frame: 1 day). 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 31 Aug 2018.