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Macular HolesPhase 4NCT04346095

Oral Sedation in Vitreoretinal Surgery

A Phase 4 study testing Oral Sedatives with or Without Analgesia and Intravenous Sedatives with or Without Analgesia in people with Macular Holes and Intraocular Lens Opacification, run by Rocky Vista University, LLC.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Oral Sedatives with or Without Analgesia and Intravenous Sedatives with or Without Analgesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Jun 2020to Nov 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

About this study

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

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

Read the 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.

Being tested
Oral Sedatives with or Without Analgesia, Intravenous Sedatives with or Without Analgesia
Keywords
Sedation during Vitreoretinal surgery, Oral Sedation, Anesthesia in Vitreoretinal Surgery, Oral Triazolam
Medical subject headings
Retinal Perforations, Vitreous Hemorrhage, Retinal Detachment, Epiretinal Membrane, Vitreous Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Sedatives with or Without AnalgesiaDrug

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

  • Intravenous Sedatives with or Without AnalgesiaDrug

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

Study groups in NCT04346095
Study groupRoleWhat they receive
Oral SedativeExperimentalParticipants 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.
Receives: Drug: Oral Sedatives with or Without Analgesia
Intravenous SedativeActive comparatorThis 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.
Receives: Drug: Intravenous Sedatives with or Without Analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: A patient satisfaction survey will be completed at the one-day post operative appointment.

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study startJun 2020 (estimated)
  3. Primary completionOct 2020 (estimated)
  4. Study completionNov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization comparing standard procedure to experimental procedure
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04346095
Sponsor's protocol ID
2020-0037
Status last verified
Apr 2020
First submitted
10 Apr 2020
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10701034

  • 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.

    PubMed 31002834

  • 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.

    PubMed 17392854

  • 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.

    PubMed 25661136

  • 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.

    PubMed 17900211

  • 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.

    PubMed 21519043

  • 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.

    PubMed 1739718

  • 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral Sedatives with or Without Analgesia and Intravenous Sedatives with or Without Analgesia in people with Macular Holes and Intraocular Lens Opacification, run by Rocky Vista University, LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction: scale (time frame: A patient satisfaction survey will be completed at the one-day post operative appointment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04346095, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.

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