Oral Sedation in Vitreoretinal Surgery

Phase 4

• Conditions: Epiretinal Membrane; Vitrectomy; Macular Holes; Retinal Detachment; Vitreous Detachment; Intraocular Lens Opacification; Intraocular Lens Dislocation; Vitreous Hemorrhage
• Interventions: Drug: Oral Sedatives with or Without Analgesia; Drug: Intravenous Sedatives with or Without Analgesia

• Registration Number: NCT04346095
• Lead Sponsor: Rocky Vista University, LLC

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-15
• Last Update Posted: 2020-04-15
• Study Start: 2020-06
• Primary Completion: 2020-10
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Sedative	Oral Sedatives with or Without Analgesia	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.
Intravenous Sedative	Intravenous Sedatives with or Without Analgesia	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.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction: scale	A patient satisfaction survey will be completed at the one-day post operative appointment.	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.

Secondary Outcome Measures

Name	Time	Method
Surgeon satisfaction: survey	The survey will be completed 10-15 minutes following the completion of the surgery.	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.