Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Sedation in Vitreoretinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346095
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Erica Podesto, Rocky Vista University, LLC

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

Condition or disease Intervention/treatment Phase
Macular Holes Intraocular Lens Opacification Vitrectomy Vitreous Hemorrhage Retinal Detachment Epiretinal Membrane Vitreous Detachment Intraocular Lens Dislocation Drug: Oral Sedatives with or Without Analgesia Drug: Intravenous Sedatives with or Without Analgesia Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization comparing standard procedure to experimental procedure
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Analysis of Oral Sedation Versus Standard Intravenous Sedation in Vitreoretinal Surgery With Topical Anesthesia and Sub-tenon's Block
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral Sedative

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

Active Comparator: Intravenous Sedative

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




Primary Outcome Measures :
  1. Patient satisfaction: scale [ Time Frame: A patient satisfaction survey will be completed at the one-day post operative appointment. ]
    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 :
  1. Surgeon satisfaction: survey [ Time Frame: The survey will be completed 10-15 minutes following the completion of the surgery. ]
    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.


Other Outcome Measures:
  1. Anesthesiology satisfaction: survey [ Time Frame: The survey will be completed 10-15 minutes following the completion of the surgery. ]
    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.

  2. Registered nurse satisfaction: survey [ Time Frame: The survey will be completed 10-15 minutes following the completion of the surgery. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Publications:
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/.

Layout table for additonal information
Responsible Party: Erica Podesto, OMS-II, Rocky Vista University, LLC
ClinicalTrials.gov Identifier: NCT04346095    
Other Study ID Numbers: 2020-0037
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Erica Podesto, Rocky Vista University, LLC:
Sedation during Vitreoretinal surgery
Oral Sedation
Anesthesia in Vitreoretinal Surgery
Oral Triazolam
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Detachment
Retinal Perforations
Epiretinal Membrane
Vitreous Hemorrhage
Vitreous Detachment
Lens Subluxation
Hemorrhage
Dissociative Disorders
Pathologic Processes
Mental Disorders
Retinal Diseases
Eye Diseases
Eye Hemorrhage
Lens Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs