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The purpose of this study is to evaluate patient satisfaction after eye surgery when given a capsule compared to an intravenous (IV) dose of sedation (calming medication).
Each subject will be given a capsule and an IV in the hospital before their procedure starts, however they will not know which one is the sedation route. Each subject will have their planned surgical procedure as previously discussed with their doctor. After the procedure is completed, the doctors will complete satisfaction surveys. The subject will also complete a satisfaction survey during their regularly scheduled visit the day after surgery. Once the subject completes this survey, their study participation will be complete.
The hypothesis is that there will be no difference in patient satisfaction when given a capsule in comparison to IV sedation. If the results of the study support this hypothesis, a capsule could be used in place of IV sedation. By using a capsule for ocular procedures, both patients and the medical practice would benefit: patient would be able to eat before their procedure, patient costs would be decreased, hospital costs would be reduced, and some of these procedures would be given the option to move to a procedure room (freeing up operating room time for other departments).
The primary objective of this study is to compare patient satisfaction of oral triazolam to IV midazolam when administered for ocular procedures. Midazolam is an FDA-approved intravenous medication commonly used as a sedative for ocular procedures conducted in the operating room. This study will compare the use of triazolam, an FDA-approved oral sedative for the same types of ocular procedures, a purpose which has not fully been investigated. The benzodiazepine triazolam was chosen as the oral medication due to its similarity to midazolam. The similarities between midazolam and triazolam include similar half-life, risks, and patient experience.The medication doses were chosen from current SOC use based on weight. The lower dose for both medications are used for patients with a BMI less than 35 and the higher dose is used for patients with a BMI greater than or equal to 35.
This is the first double-blind, prospective clinical trial that will compare IV and oral sedation for multiple ocular sub-specialty procedures. The procedures to be investigated include: cataract, retina, cornea, and glaucoma surgical groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract Procedures | Experimental | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
|
| Retina Procedures | Experimental | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
|
| Cornea Procedures | Experimental | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triazolam | Drug | This will be used for oral sedation. This capsule or a microcrystalline cellulose placebo capsule will be administered depending on the randomized treatment group. Dose for BMI less than 35: 0.125 mg Dose for BMI greater than or equal to 35: 0.25 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patient satisfaction will be determined by completion of a 12 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per patient. Higher mean scores are associated with higher levels of satisfaction. | The patient satisfaction survey was administered up to two days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Satisfaction | Surgeon satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per surgeon Higher mean scores are associated with higher levels of satisfaction. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Additional Anesthesia Intervention | The number of subjects in each arm that received additional anesthetic agents during the operative procedure after the initial sedation. | Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure. |
Inclusion Criteria:
Age 18 years or older
Ability to speak and read in English or Spanish or Haitian Creole
Subjects able to consent for themselves
Outpatient surgical plan for any of the following procedures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manju Subramanian, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26804760 | Background | Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology. 2016 Apr;123(4):723-8. doi: 10.1016/j.ophtha.2015.12.020. Epub 2016 Jan 22. | |
| 21307770 | Background | American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available. |
| Label | URL |
|---|---|
| Midazolam Drug Label Information | View source |
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Out of 327 patients enrolled, 283 completed study participation and 44 patients did not complete study participation as they were dropped or withdrew from the study. 22 patients were dropped before randomization and 22 patients discontinued from study after randomization due to reasons seen in the participant flow table.
Patients were recruited from October 26th, 2017 to November 30th, 2019 at the outpatient eye clinic, Ophthalmology Department, Boston Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cataract Procedures | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| FG001 | Retina Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| FG002 | Cornea Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| FG003 | Glaucoma Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The data displays information for participants that complete study participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cataract Procedures | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
Triazolam or microcrystalline cellulose oral placebo: Administered 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 Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Satisfaction | Patient satisfaction will be determined by completion of a 12 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per patient. Higher mean scores are associated with higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | The patient satisfaction survey was administered up to two days after surgery. |
|
Adverse events were noted during the surgery and up to two days after the surgery when the patient satisfaction survey was administered.
The same definition of adverse events and serious adverse events as clinicaltrials.gov. With the exception of hypertension, all other adverse events were not related to a particular organ system and occurred as a result of the surgical procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cataract Procedures | The following ocular procedures will fall under this arm of the study: • Cataracts Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| In-patient Hospitalization | Surgical and medical procedures | Non-systematic Assessment | Patient experienced pain and unease during surgery, and nausea, and malaise after surgery. The intervention was in-patient hospitalization. SAE was unexpected and the severity grade of SAE was 3. SAE was resolved on day of surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain During Surgery | Surgical and medical procedures | Non-systematic Assessment | The patient experienced pain and up to two days after surgery (in the eye, chest, back). The pain varied in severity and was self-reported by patients when the patient satisfaction survey was administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marissa Fiorello, Clinical Research Manager | Boston Medical Center | 617-414-8848 | Marissa.Fiorello@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2019 | Jul 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014229 | Triazolam |
| D008874 | Midazolam |
| C109691 | microcrystalline cellulose |
| D002482 | Cellulose |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Interventions: triazolam oral sedation with sodium chloride 0.9% IV placebo or microcrystalline cellulose oral placebo with midazolam IV sedation
Subjects will be randomized (1:1) to one of the two study arms listed above. On the day of surgery, the subject, anesthesiologist/CRNA, and surgeon will be blinded to the treatment assignment. The anesthesiologist/CRNA or pre-operative nurses will administer the blinded oral medication approximately 30 minutes before the procedure beings. The anesthesiologist/CRNA will administer the blinded IV medication approximately 5 minutes before the procedure begins. At the completion of the procedure, the anesthesiologist/CRNA and the surgeon will complete a satisfaction survey. The subject will then return within 2 days for their first post-operative clinical visit and complete a satisfaction survey.
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The subject and their entire medical team (including the anesthesiologist and surgeon) will all be masked to the subject's randomized intervention group. The randomization groups will be assigned by the statistician who will be unmasked. All medications will be provided to the medical team on the day of the procedure completely masked. The clinical research coordinator, the clinical research assistant, and the pharmacy will be unmasked to the intervention group. Any member of the medical team can be unmasked at any time after the intervention is administered in the case of an emergency resulting in a serious adverse event or an unanticipated problem.
|
| Glaucoma Procedures | Experimental | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
|
|
| Midazolam | Drug | This will be used for intravenous sedation. This injection or sodium chloride 0.9% will be administered depending on the randomized treatment group. Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg |
|
|
| Microcrystalline Cellulose | Drug | This will be used for the oral placebo. This capsule or a triazolam capsule will be administered depending on the randomized treatment group. Dose for BMI less than 35: 1 capsule Dose for BMI greater than or equal to 35: 2 capsule |
|
|
| Sodium chloride 0.9% | Drug | This will be used for the intravenous placebo.This injection or midazolam will be administered depending on the randomized treatment group. Dose for BMI less than 35: volume to match volume of active intravenous medication Dose for BMI greater than or equal to 35: volume to match volume of active intravenous medication |
|
|
| The surgeon satisfaction survey will be administered immediately after the completion of the surgery. . |
| Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction | Anesthesiologist/CRNA satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per anesthesiologist/CRNA. Higher mean scores are associated with higher levels of satisfaction. | The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case. |
| Surgical Complication Rates |
The number of subjects in each arm that experienced a complication during the operative procedure after the initial sedation. |
| Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure. |
| 9180592 | Background | Campbell J. Intravenous cannulation: potential complications. Prof Nurse. 1997 May;12(8 Suppl):S10-3. |
| 22273990 | Background | Committee on Standards and Practice Parameters; Apfelbaum JL, Connis RT, Nickinovich DG; American Society of Anesthesiologists Task Force on Preanesthesia Evaluation; Pasternak LR, Arens JF, Caplan RA, Connis RT, Fleisher LA, Flowerdew R, Gold BS, Mayhew JF, Nickinovich DG, Rice LJ, Roizen MF, Twersky RS. Practice advisory for preanesthesia evaluation: an updated report by the American Society of Anesthesiologists Task Force on Preanesthesia Evaluation. Anesthesiology. 2012 Mar;116(3):522-38. doi: 10.1097/ALN.0b013e31823c1067. No abstract available. |
| 15920188 | Result | Fung D, Cohen M, Stewart S, Davies A. Can the Iowa Satisfaction with Anesthesia Scale be used to measure patient satisfaction with cataract care under topical local anesthesia and monitored sedation at a community hospital? Anesth Analg. 2005 Jun;100(6):1637-1643. doi: 10.1213/01.ANE.0000154203.00434.23. |
| 18465717 | Result | Erdurmus M, Aydin B, Usta B, Yagci R, Gozdemir M, Totan Y. Patient comfort and surgeon satisfaction during cataract surgery using topical anesthesia with or without dexmedetomidine sedation. Eur J Ophthalmol. 2008 May-Jun;18(3):361-7. doi: 10.1177/112067210801800308. |
| Ineligible on day of surgery |
|
| Study completed before surgical date |
|
| Transferred to other arm |
|
| Unable to obtain medication timely |
|
| Re-consented to participate |
|
| BG001 | Retina Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
Triazolam or microcrystalline cellulose oral placebo: Administered 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 Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg |
| BG002 | Cornea Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
Triazolam or oral placebo: Administered 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 Midazolam or sodium chloride 0.9%: Administered 5 minutes prior to surgery Dose for BMI less than 35: 1.0 mg Dose for BMI greater than or equal to 35: 2.0 mg |
| BG003 | Glaucoma Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
Triazolam or placebo: Given 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 Midazolam or placebo: Given 5 minutes prior to surgery Dose for BMI less than 35: 1. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Language | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Retina Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| OG002 | Cornea Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
| OG003 | Glaucoma Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
|
|
|
|
| Secondary | Surgeon Satisfaction | Surgeon satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per surgeon Higher mean scores are associated with higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | The surgeon satisfaction survey will be administered immediately after the completion of the surgery. . |
|
|
|
|
| Secondary | Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction | Anesthesiologist/CRNA satisfaction will be determined by completion of a 5 question satisfaction survey. The responses to each question will be graded on a scale from 1 to 6: 1 being the least satisfied and 6 being the most satisfied. After all answers are graded for one survey, they will be averaged to give an overall survey grade on the 1 to 6 scale per anesthesiologist/CRNA. Higher mean scores are associated with higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case. |
|
|
|
|
| Other Pre-specified | Number of Participants Requiring Additional Anesthesia Intervention | The number of subjects in each arm that received additional anesthetic agents during the operative procedure after the initial sedation. | Posted | Count of Participants | Participants | Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure. |
|
|
|
|
| Other Pre-specified | Surgical Complication Rates | The number of subjects in each arm that experienced a complication during the operative procedure after the initial sedation. | Data was not available for one participant in the cornea arm. | Posted | Count of Participants | Participants | Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure. |
|
|
|
|
| 0 |
| 85 |
| 1 |
| 85 |
| 8 |
| 85 |
| EG001 | Retina Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
| 0 | 84 | 0 | 84 | 17 | 84 |
| EG002 | Cornea Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
| 0 | 70 | 0 | 70 | 6 | 70 |
| EG003 | Glaucoma Procedures | The following ocular procedures will fall under this arm of the study:
Each subject will receive a capsule and an intravenous injection; however, they will not know which one is administering the sedation. Each patient will be randomized to one of the two groups listed below within this arm of the study:
| 0 | 44 | 0 | 44 | 6 | 44 |
|
|
| Nausea & Vomiting Post-surgery | Surgical and medical procedures | Non-systematic Assessment | The patient experienced nausea and vomiting after surgery. This was self-reported, varied in severity, and was recorded when the patient satisfaction survey was administered. |
|
| Headache & Dizziness | Surgical and medical procedures | Non-systematic Assessment | The patient experienced headache and/or dizziness after surgery. This was self-reported, varied in severity, and was recorded when the patient satisfaction survey was administered. |
|
| Hypertension | Vascular disorders | Non-systematic Assessment | The patient experienced hypertension after surgery. This was self-reported, varied in severity, and was recorded when the patient satisfaction survey was administered. |
|
| Anxiety | Surgical and medical procedures | Non-systematic Assessment | The patient experienced anxiety before and during surgery. This was self-reported, varied in severity, and was recorded on the day of the surgery. |
|
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| D006571 | Heterocyclic Compounds |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Non-Inferiority |
A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative. |
| Non-Inferiority |
A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative. |