Oral Sedation in Vitreoretinal Surgery

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-11-30

Brief Summary

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The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.

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Detailed Description

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After being informed about the study and potential risks, and providing written informed consent, a total of 40 patients will undergo vitreoretinal surgery with oral Triazolam and 40 patients will undergo vitreoretinal surgery with intravenous sedation. The IV sedative will be determined by the anesthesiologist or certified registered nurse anesthetist but limited to midazolam, propofol, and fentanyl. The study will be a prospective, cross-sectional study with a 1:1 randomized procedure and unmasked.

Conditions

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Macular Holes Intraocular Lens Opacification Vitrectomy Vitreous Hemorrhage Retinal Detachment Epiretinal Membrane Vitreous Detachment Intraocular Lens Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization comparing standard procedure to experimental procedure

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Sedative

Participants will receive oral triazolam 30 minutes prior to surgery.

Dose for BMI less than 35: 0.125 mg

Dose for BMI greater than or equal to 35: 0.25 mg

Followed by topical proparacaine and 6 cc sub-tenon's mixture of lidocaine and marcaine.

Vitals will monitored by the operating room nurses.

Group Type EXPERIMENTAL

Oral Sedatives with or Without Analgesia

Intervention Type DRUG

The participants will receive oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.

Intravenous Sedative

This group will receive an intravenous sedative. The sedative is limited to midazolam, fentanyl, propofol.

Follow by topical proparacaine and 6 cc sub-tenon's mixture of lidocaine and marcaine.

IV and monitoring will be performed by anesthesiologist or CRNA.

Group Type ACTIVE_COMPARATOR

Intravenous Sedatives with or Without Analgesia

Intervention Type DRUG

The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.

Interventions

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Oral Sedatives with or Without Analgesia

The participants will receive oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.

Intervention Type DRUG

Intravenous Sedatives with or Without Analgesia

The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undergoing vitreoretinal surgery for a variety of indications including, but not limited to, epiretinal membrane (ERM), macular hole, vitreous opacities, vitreous hemorrhage, aphakia, dislocated or displaced intraocular or crystalline lens, silicone removal, endolaser, and retinal detachment.
* American Society of Anesthesiologists rating of I-III

Exclusion Criteria

* Undergoing vitreoretinal surgery requiring general anesthesia
* Allergy or hypersensitivity to benzodiazepines
* Pregnant or nursing females
* Previous delirium after anesthesia
* Current use of drug or alcohol on the day of surgery
* Currently on medications inhibiting cytochrome P450
* Failed anesthesia clearance
* Reported anxiety or a history of anxiolytic use
* Vitreoretinal surgery performed within the last 3 months of the current procedure
* Impaired renal or liver function

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes