SurgeryPhase 4NCT03246724
Oral Versus Intravenous Sedation for Ocular Procedures
A Phase 4 study testing Triazolam, Midazolam and Microcrystalline Cellulose in people with Surgery and Sedation, run by Boston Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Triazolam, Midazolam and Microcrystalline Cellulose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 30 Nov 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Cataract surgery: cataracts
- Retina: pars plana vitrectomy, pars plana vitrectomy with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal
- Cornea: descemet stripping endothelial keratopathy, cataracts with descemet stripping endothelial keratopathy, descemet membrane endothelial keratoplasty, cataracts with descemet membrane endothelial keratoplasty, conjunctival and/or corneal lesion excisions, pterygium
- Glaucoma: ahmed valve, ahmed valve with cataracts,trabeculectomy, trabeculectomy with cataracts, baerveldt, baerveldt with cataracts, endocyclophotocoagulation, endocyclophotocoagulation with cataracts, istent, istent with cataracts, kahook, kahook with cataracts, cypass, cypass with cataracts
Who cannot join
- Surgical plan which includes general anesthesia
- Hypersensitivity or allergy to benzodiazepines
- Women who are pregnant, have a positive pregnancy test on the day of surgery, refuse a pregnancy test, or are nursing
- Previous delirium after anesthesia with a benzodiazepine
- Subjects 70 years of age or older who fail the delirium pre-screening questionnaire as shown in Appendix Section 15.6
- Currently experiencing the effects of drug/alcohol
Show all 10Show fewer
- Current oral/IV regimen of any medication inhibiting cytochrome P450 3A which includes ketoconazole, itraconazole, nefazodone, ritonavir, indinavir, nelavir, saquinavir, and lopinavir
- Subjects already enrolled in this study for the fellow eye
- Subjects enrolled in a clinical trial with an investigational drug within the past 3 months
- Failed anesthesia clearance to receive a benzodiazepine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing Oral Sedation to Intravenous Sedation for Ocular Procedures.
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).
Read the detailed description
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.
- Being tested
- Triazolam, Midazolam, Microcrystalline Cellulose, Sodium chloride 0.9%
- Keywords
- Ocular surgery, Intravenous sedation, Oral sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriazolamDrug
Also called Halcion
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
MidazolamDrug
Also called Versed
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 CelluloseDrug
Also called Avicel
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
Also called Normal Saline
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
| Study group | Role | What they receive |
|---|---|---|
| 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:
* Triazolam oral sedation with sodium chloride 0.9% intravenous placebo
* Microcrystalline cellulose oral placebo with midazolam intravenous sedation Receives: Drug: Triazolam; Drug: Midazolam; Drug: Microcrystalline Cellulose; Drug: Sodium chloride 0.9% |
| Retina Procedures | Experimental | The following ocular procedures will fall under this arm of the study:
* Pars plana vitrectomy
* Pars plana vitrectomy with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal
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 oral sedation with sodium chloride 0.9% intravenous placebo
* Microcrystalline cellulose oral placebo with midazolam intravenous sedation Receives: Drug: Triazolam; Drug: Midazolam; Drug: Microcrystalline Cellulose; Drug: Sodium chloride 0.9% |
| Cornea Procedures | Experimental | The following ocular procedures will fall under this arm of the study:
* Descemet Stripping Endothelial Keratoplasty (DSEK)
* Cataracts with Descemet Stripping Endothelial Keratoplasty (DSEK)
* Descemet Membrane Endothelial Keratoplasty (DMEK)
* Cataracts with Descemet Membrane Endothelial Keratoplasty (DMEK)
* Conjunctival and/or corneal lesion excisions
* Pterygium
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 oral sedation with sodium chloride 0.9% intravenous placebo
* Microcrystalline cellulose oral placebo with midazolam intravenous sedation Receives: Drug: Triazolam; Drug: Midazolam; Drug: Microcrystalline Cellulose; Drug: Sodium chloride 0.9% |
| Glaucoma Procedures | Experimental | The following ocular procedures will fall under this arm of the study:
* Ahmed valve
* Ahmed valve with cataracts
* Trabeculectomy
* Trabeculectomy with cataracts
* Baerveldt
* Baerveldt with cataracts
* Endocyclophotocoagulation
* Endocyclophotocoagulation with cataracts
* Istent
* Cataracts with istent
* Kahook
* Cataracts with kahook
* Cypass
* Cypass with 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 oral sedation with sodium chloride 0.9% intravenous placebo
* Microcrystalline cellulose oral placebo with midazolam intravenous sedation Receives: Drug: Triazolam; Drug: Midazolam; Drug: Microcrystalline Cellulose; Drug: Sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The patient satisfaction survey was administered up to two days after surgery.
Secondary outcomes (2)
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.
Measured: 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.
Measured: The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start16 Oct 2017
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manju Subramanian, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246724
- Sponsor's protocol ID
- H-36590
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2017
- Last updated
- 19 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26804760American 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.
PubMed 21307770Campbell J. Intravenous cannulation: potential complications. Prof Nurse. 1997 May;12(8 Suppl):S10-3.
PubMed 9180592Committee 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.
PubMed 22273990Fung 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.
PubMed 15920188Erdurmus 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.
PubMed 18465717
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing Oral Sedation to Intravenous Sedation for Ocular Procedures.
- ClinicalTrials.gov ID
- NCT03246724
- Acronym / sponsor ID
- H-36590
- Keywords
- Ocular surgery, Intravenous sedation, Oral sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Posted 19 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cataract Procedures | Experimental | Drug: Triazolam, Drug: Midazolam, Drug: Microcrystalline Cellulose, Drug: Sodium chloride 0.9%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 oral sedation with sodium chloride 0.9% intravenous placebo * Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Retina Procedures | Experimental | Drug: Triazolam, Drug: Midazolam, Drug: Microcrystalline Cellulose, Drug: Sodium chloride 0.9%The following ocular procedures will fall under this arm of the study: * Pars plana vitrectomy * Pars plana vitrectomy with cataracts, epiretinal membrane peel, pars plana lensectomy, and/or endolaser, silicone oil removal 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 oral sedation with sodium chloride 0.9% intravenous placebo * Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Cornea Procedures | Experimental | Drug: Triazolam, Drug: Midazolam, Drug: Microcrystalline Cellulose, Drug: Sodium chloride 0.9%The following ocular procedures will fall under this arm of the study: * Descemet Stripping Endothelial Keratoplasty (DSEK) * Cataracts with Descemet Stripping Endothelial Keratoplasty (DSEK) * Descemet Membrane Endothelial Keratoplasty (DMEK) * Cataracts with Descemet Membrane Endothelial Keratoplasty (DMEK) * Conjunctival and/or corneal lesion excisions * Pterygium 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 oral sedation with sodium chloride 0.9% intravenous placebo * Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
| Glaucoma Procedures | Experimental | Drug: Triazolam, Drug: Midazolam, Drug: Microcrystalline Cellulose, Drug: Sodium chloride 0.9%The following ocular procedures will fall under this arm of the study: * Ahmed valve * Ahmed valve with cataracts * Trabeculectomy * Trabeculectomy with cataracts * Baerveldt * Baerveldt with cataracts * Endocyclophotocoagulation * Endocyclophotocoagulation with cataracts * Istent * Cataracts with istent * Kahook * Cataracts with kahook * Cypass * Cypass with 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 oral sedation with sodium chloride 0.9% intravenous placebo * Microcrystalline cellulose oral placebo with midazolam intravenous sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (10 listed)
- Surgical plan which includes general anesthesia
- Hypersensitivity or allergy to benzodiazepines
- Women who are pregnant, have a positive pregnancy test on the day of surgery, refuse a pregnancy test, or are nursing
- Previous delirium after anesthesia with a benzodiazepine
- Subjects 70 years of age or older who fail the delirium pre-screening questionnaire as shown in Appendix Section 15.6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriazolamAlso: HalcionThis 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 | Drug | Cataract Procedures, Cornea Procedures, Glaucoma Procedures, Retina Procedures |
| MidazolamAlso: VersedThis 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 | Drug | Cataract Procedures, Cornea Procedures, Glaucoma Procedures, Retina Procedures |
| Microcrystalline CelluloseAlso: AvicelThis 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 | Drug | Cataract Procedures, Cornea Procedures, Glaucoma Procedures, Retina Procedures |
| Sodium chloride 0.9%Also: Normal SalineThis 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 | Drug | Cataract Procedures, Cornea Procedures, Glaucoma Procedures, Retina Procedures |
Primary outcome
Patient Satisfaction
Time frame: The patient satisfaction survey was administered up to two days after surgery.
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.
2 secondary outcomes
Surgeon Satisfaction
Time frame: The surgeon satisfaction survey will be administered immediately after the completion of the surgery. .
Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction
Time frame: The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26804760Ianchulev 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.
- Background: PubMed 21307770American 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.
- Background: PubMed 9180592Campbell J. Intravenous cannulation: potential complications. Prof Nurse. 1997 May;12(8 Suppl):S10-3.
- Background: PubMed 22273990Committee 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.
- Results publication: PubMed 15920188Fung 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.
- Results publication: PubMed 18465717Erdurmus 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.
- Midazolam Drug Label InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manju Subramanian, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triazolam, Midazolam and Microcrystalline Cellulose in people with Surgery and Sedation, run by Boston Medical Center at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 19 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: The patient satisfaction survey was administered up to two days after surgery.). 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 NCT03246724, which also lists 6 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 19 Aug 2020.