Oral Versus Intravenous Sedation for Ocular Procedures

NCT03246724 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: H-36590
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Surgery; Sedation

Keywords

Ocular surgery; Intravenous sedation; Oral sedation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Surgeon Satisfaction

  The surgeon satisfaction survey will be administered immediately after the completion of the surgery. .

• Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Satisfaction

  The anesthesiologist/CRNA satisfaction survey will be administered immediately after the completion of the surgical case.

Other Outcomes (2)

• Number of Participants Requiring Additional Anesthesia Intervention

  Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure.

• Surgical Complication Rates

  Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure.

Study Arms (4)

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

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

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

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

Drug: Triazolam; Drug: Midazolam; Drug: Microcrystalline Cellulose; Drug: Sodium chloride 0.9%

Interventions

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

Also known as: Halcion

Cataract Procedures; Cornea Procedures; Glaucoma Procedures; Retina Procedures

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

Also known as: Versed

Cataract Procedures; Cornea Procedures; Glaucoma Procedures; Retina Procedures

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

Also known as: Avicel

Cataract Procedures; Cornea Procedures; Glaucoma Procedures; Retina Procedures

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

Also known as: Normal Saline

Cataract Procedures; Cornea Procedures; Glaucoma Procedures; Retina Procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (6)

• 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.

  PMID: 26804760 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.

  PMID: 21307770 BACKGROUND

• Campbell J. Intravenous cannulation: potential complications. Prof Nurse. 1997 May;12(8 Suppl):S10-3.

  PMID: 9180592 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.

  PMID: 22273990 BACKGROUND

• 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.

  PMID: 15920188 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.

  PMID: 18465717 RESULT

Related Links

• Midazolam Drug Label Information

MeSH Terms

Interventions

Triazolam; Midazolam; microcrystalline cellulose; Cellulose; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Marissa Fiorello, Clinical Research Manager
• Organization: Boston Medical Center

Marissa.Fiorello@bmc.org

617-414-8848

Study Officials

• Manju Subramanian, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 11, 2017
• Study Start: October 16, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)