Oral Sedation in Vitreoretinal Surgery

Rocky Vista University, LLC

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Intravenous Sedatives with or Without Analgesia; Drug: Oral Sedatives with or Without Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04346095

2020-0037

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Oral Sedative

Experimental group

Description:

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.

Treatment:

Drug: Oral Sedatives with or Without Analgesia

Intravenous Sedative

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous Sedatives with or Without Analgesia