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Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

NCT ID: NCT03653520

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

651 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2017-11-04

Brief Summary

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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

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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

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
The surgeon was not aware which medication the patient received

Study Groups

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diazepam only (group 1)

Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type DRUG

5 or 10mg

diazepam/tramadol/ondansetron (group 2)

Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type DRUG

5 or 10mg

Tramadol

Intervention Type DRUG

50mg or 100mg

Ondansetron

Intervention Type DRUG

1 or two tabs

MKO only (group 3)

Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation

Group Type EXPERIMENTAL

MKO melt

Intervention Type DRUG

1 or 2 MKO melts

Interventions

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Diazepam

5 or 10mg

Intervention Type DRUG

Tramadol

50mg or 100mg

Intervention Type DRUG

Ondansetron

1 or two tabs

Intervention Type DRUG

MKO melt

1 or 2 MKO melts

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avanti Anesthesia

OTHER

Sponsor Role lead

Responsible Party

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Maggie Jeffries

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maggie Jeffries, MD

Role: PRINCIPAL_INVESTIGATOR

Avanti Anesthesia

Locations

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Memorial Hermann Kirby Glen Surgery Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ANES001

Identifier Type: -

Identifier Source: org_study_id