Oral Sedation in Vitreoretinal Surgery

NCT04346095 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2020-0037
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Surgeon satisfaction: survey

  The survey will be completed 10-15 minutes following the completion of the surgery.

Other Outcomes (2)

• Anesthesiology satisfaction: survey

  The survey will be completed 10-15 minutes following the completion of the surgery.

• Registered nurse satisfaction: survey

  The survey will be completed 10-15 minutes following the completion of the surgery.

Study Arms (2)

Oral Sedative

EXPERIMENTAL

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

Intravenous Sedative

ACTIVE COMPARATOR

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

Interventions

Oral Sedatives with or Without Analgesia DRUG

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

Oral Sedative

Intravenous Sedatives with or Without Analgesia DRUG

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

Intravenous Sedative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rocky Vista University, LLC: lead

Related Publications (8)

• 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.

  PMID: 10701034 BACKGROUND

• 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.

  PMID: 31002834 BACKGROUND

• 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.

  PMID: 17392854 BACKGROUND

• 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.

  PMID: 25661136 BACKGROUND

• 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.

  PMID: 17900211 BACKGROUND

• 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.

  PMID: 21519043 BACKGROUND

• 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.

  PMID: 1739718 BACKGROUND

• 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/.

  BACKGROUND

MeSH Terms

Conditions

Retinal Perforations; Vitreous Hemorrhage; Retinal Detachment; Epiretinal Membrane; Vitreous Detachment

Interventions

Hypnotics and Sedatives; Analgesia

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OMS-II

Model Details: 1:1 randomization comparing standard procedure to experimental procedure

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: June 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share