A Phase 4 interventional study of Oral Sedatives with or Without Analgesia and Intravenous Sedatives with or Without Analgesia in Macular Holes, Intraocular Lens Opacification and Vitrectomy, sponsored by Rocky Vista University, LLC. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by Rocky Vista University, LLC · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.
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.
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 136 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Rocky Vista University, LLC is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
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 oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.
The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.
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.
Time frame: A patient satisfaction survey will be completed at the one-day post operative appointment.
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.
Time frame: The survey will be completed 10-15 minutes following the completion of the surgery.
Anesthesiology satisfaction: survey
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.
Registered nurse satisfaction: survey
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.
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Rocky Vista University, LLC