search
Back to results

Oral Sedation in Vitreoretinal Surgery

Primary Purpose

Macular Holes, Intraocular Lens Opacification, Vitrectomy

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oral Sedatives with or Without Analgesia
Intravenous Sedatives with or Without Analgesia
Sponsored by
Rocky Vista University, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes focused on measuring Sedation during Vitreoretinal surgery, Oral Sedation, Anesthesia in Vitreoretinal Surgery, Oral Triazolam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Oral Sedative

    Intravenous Sedative

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 10, 2020
    Last Updated
    April 14, 2020
    Sponsor
    Rocky Vista University, LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04346095
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    October 2020 (Anticipated)
    Study Completion Date
    November 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rocky Vista University, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    1:1 randomization comparing standard procedure to experimental procedure
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral Sedative
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Intravenous Sedative
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Oral Sedatives with or Without Analgesia
    Intervention Description
    The participants will receive oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Sedatives with or Without Analgesia
    Intervention Description
    The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.
    Primary Outcome Measure Information:
    Title
    Patient satisfaction: scale
    Description
    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.
    Time Frame
    A patient satisfaction survey will be completed at the one-day post operative appointment.
    Secondary Outcome Measure Information:
    Title
    Surgeon satisfaction: survey
    Description
    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.
    Time Frame
    The survey will be completed 10-15 minutes following the completion of the surgery.
    Other Pre-specified Outcome Measures:
    Title
    Anesthesiology satisfaction: survey
    Description
    The surgeon will complete a survey 10-15 minutes following the completion of the surgery. The survey will include a 5 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 question will be included to the survey with a statement requiring that the participant rate the accuracy of statement with 1 representing strong agreement and 6 representing strong disagreement. After all questions have been answered, the scaled questions will be analyzed for an average score out of 6 per patient. The scaled questions will be used to determine the non-inferiority of the experimental treatment.
    Time Frame
    The survey will be completed 10-15 minutes following the completion of the surgery.
    Title
    Registered nurse satisfaction: survey
    Description
    The nurse assigned to the case will complete a survey 10-15 minutes following the completion of the surgery. The survey will include a 6 question survey with a statement regarding the nurse'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.
    Time Frame
    The survey will be completed 10-15 minutes following the completion of the surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10701034
    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.
    Results Reference
    background
    PubMed Identifier
    31002834
    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.
    Results Reference
    background
    PubMed Identifier
    17392854
    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.
    Results Reference
    background
    PubMed Identifier
    25661136
    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.
    Results Reference
    background
    PubMed Identifier
    17900211
    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.
    Results Reference
    background
    PubMed Identifier
    21519043
    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.
    Results Reference
    background
    PubMed Identifier
    1739718
    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.
    Results Reference
    background
    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/.
    Results Reference
    background

    Learn more about this trial

    Oral Sedation in Vitreoretinal Surgery

    We'll reach out to this number within 24 hrs