Oral Sedation in Vitreoretinal Surgery

Study Overview
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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.

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.

Official Title
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Comparative Analysis of Oral Sedation Versus Standard Intravenous Sedation in Vitreoretinal Surgery With Topical Anesthesia and Sub-tenon's Block

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

Intervention / Treatment
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* Drug: Oral Sedatives with or Without Analgesia
* Drug: Intravenous Sedatives with or Without Analgesia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization comparing standard procedure to experimental procedure
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Sedative<br>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. | Drug: Oral Sedatives with or Without Analgesia<br>* The participants will receive oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.<br>|
| Active Comparator: Intravenous Sedative<br>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. | Drug: Intravenous Sedatives with or Without Analgesia<br>* The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction: scale | The patient will complete a survey at the one-day post-operative appointment. The survey consists of statements regarding the surgical procedure and experience with a scale of 1 to 6 demonstrating the patient's agreement or disagreement with the statement. Additional questions regarding the surgery and not using the 1 to 6 model will also be asked in the same survey. There will be 14 questions in the 1-6 scale portion of the survey and 4 additional questions. After all questions have been answered, the scaled questions will be analyzed for an average score out of 6 per patient. Additional questions will be analyzed by percentage of each answer. The scaled questions will be used to determine the non-inferiority of the experimental treatment. Additional questions will not be included in the non-inferiority analysis but results will be included in the study. | A patient satisfaction survey will be completed at the one-day post operative appointment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon satisfaction: survey | The surgeon will complete a survey 10-15 minutes following the completion of the surgery. The survey will include a 6 question survey with statement regarding the surgeon's experience. The surgeon will be asked to rate the statement's accuracy from a scale of 1 to 6 with 1 demonstrating strong disagreement and 6 demonstrating strong agreement. An additional yes or no question will be asked. After all questions have been answered, the scaled questions will be analyzed for an average score out of 6 per patient. Additional questions will be analyzed by percentage of each answer. The scaled questions will be used to determine the non-inferiority of the experimental treatment. Additional questions will not be included in the non-inferiority analysis but results will be included in the study. | The survey will be completed 10-15 minutes following the completion of the surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation during Vitreoretinal surgery, Oral Sedation, Anesthesia in Vitreoretinal Surgery, Oral Triazolam