Clinical trial NCT04346095: Oral Sedation in Vitreoretinal Surgery
Official title: Comparative Analysis of Oral Sedation Versus Standard Intravenous Sedation in Vitreoretinal Surgery With Topical Anesthesia and Sub-tenon's Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Macular Holes
Intraocular Lens Opacification
Vitrectomy
Vitreous Hemorrhage
Retinal Detachment
Epiretinal Membrane
Vitreous Detachment
Intraocular Lens Dislocation
Keywords: Sedation during Vitreoretinal surgery
Oral Sedation
Anesthesia in Vitreoretinal Surgery
Oral Triazolam
Lead sponsor: Rocky Vista University, LLC
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization comparing standard procedure to experimental procedure
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction: scale
timeFrame: A patient satisfaction survey will be completed at the one-day post operative appointment.
Secondary outcomes:
measure: Surgeon satisfaction: survey
timeFrame: The survey will be completed 10-15 minutes following the completion of the surgery.
Other outcomes:
measure: Anesthesiology satisfaction: survey
timeFrame: The survey will be completed 10-15 minutes following the completion of the surgery.
measure: Registered nurse satisfaction: survey
timeFrame: The survey will be completed 10-15 minutes following the completion of the surgery.
Locations:
Study officials:
References:
citation: Morley HR, Karagiannis A, Schultz DJ, Walker JC, Newland HS. Sedation for vitreoretinal surgery: a comparison of anaesthetist-administered midazolam and patient-controlled sedation with propofol. Anaesth Intensive Care. 2000 Feb;28(1):37-42. doi: 10.1177/0310057X0002800106.
citation: Peeler CE, Villani CM, Fiorello MG, Lee HJ, Subramanian ML; Oral versus Intravenous Sedation Study Group. Patient Satisfaction with Oral versus Intravenous Sedation for Cataract Surgery: A Randomized Clinical Trial. Ophthalmology. 2019 Sep;126(9):1212-1218. doi: 10.1016/j.ophtha.2019.04.022. Epub 2019 Apr 16.
citation: Rocha G, Turner C. Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring. Can J Ophthalmol. 2007 Apr;42(2):288-94.
citation: Chen M, Hill GM, Patrianakos TD, Ku ES, Chen ML. Oral diazepam versus intravenous midazolam for conscious sedation during cataract surgery performed using topical anesthesia. J Cataract Refract Surg. 2015 Feb;41(2):415-21. doi: 10.1016/j.jcrs.2014.06.027.
citation: Donaldson M, Gizzarelli G, Chanpong B. Oral sedation: a primer on anxiolysis for the adult patient. Anesth Prog. 2007 Fall;54(3):118-28; quiz 129. doi: 10.2344/0003-3006(2007)54[118:OSAPOA]2.0.CO;2.
citation: Dexter F, Candiotti KA. Multicenter assessment of the Iowa Satisfaction with Anesthesia Scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg. 2011 Aug;113(2):364-8. doi: 10.1213/ANE.0b013e318217f804. Epub 2011 Apr 25.
citation: Cannon CS, Gross JG, Abramson I, Mazzei WJ, Freeman WR. Evaluation of outpatient experience with vitreoretinal surgery. Br J Ophthalmol. 1992 Feb;76(2):68-71. doi: 10.1136/bjo.76.2.68.
citation: Carrie Chen, Daniel Luther, Thomas Acciavatti, Manju L Subramanian; Performing Ocular Procedures under Oral Sedation in Procedure Rooms: A Cost Analysis. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5449. doi: https://doi.org/.