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Oral Versus Intravenous Sedation for Ocular Procedures

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: NCT03246724
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Manju Subramanian, Boston Medical Center

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).


Condition or disease Intervention/treatment Phase
Surgery Sedation Drug: Triazolam Drug: Midazolam Drug: Microcrystalline Cellulose Drug: Sodium chloride 0.9% Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: A Single-center, Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing Oral Sedation to Intravenous Sedation for Ocular Procedures.
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 oral sedation with sodium chloride 0.9% intravenous placebo
  • Microcrystalline cellulose oral placebo with midazolam intravenous sedation
Drug: Triazolam

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

Other Name: Halcion

Drug: Midazolam

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

Other Name: Versed

Drug: Microcrystalline Cellulose

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

Other Name: Avicel

Drug: Sodium chloride 0.9%

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

Other Name: Normal Saline

Experimental: Retina Procedures

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

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

Other Name: Halcion

Drug: Midazolam

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

Other Name: Versed

Drug: Microcrystalline Cellulose

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

Other Name: Avicel

Drug: Sodium chloride 0.9%

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

Other Name: Normal Saline

Experimental: Cornea Procedures

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

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

Other Name: Halcion

Drug: Midazolam

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

Other Name: Versed

Drug: Microcrystalline Cellulose

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

Other Name: Avicel

Drug: Sodium chloride 0.9%

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

Other Name: Normal Saline

Experimental: Glaucoma Procedures

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

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

Other Name: Halcion

Drug: Midazolam

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

Other Name: Versed

Drug: Microcrystalline Cellulose

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

Other Name: Avicel

Drug: Sodium chloride 0.9%

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

Other Name: Normal Saline




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: The patient satisfaction survey will be 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.

    The mean satisfaction score of the oral sedation study group will be analyzed and compared to the mean satisfaction score of the IV sedation study group within surgical types.



Secondary Outcome Measures :
  1. Surgeon Satisfaction [ Time Frame: The surgeon satisfaction survey will be administered immediately after the completion of the surgical case. ]
    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.

  2. 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. ]
    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.


Other Outcome Measures:
  1. Additional Anesthesia Intervention [ Time Frame: Information regarding additional anesthesia intervention will be collected within 2 days of completion of the subjects surgical procedure. ]
    The number of subjects in each arm that receive additional anesthetic agents during the operative procedure after the initial sedation.

  2. Surgical Complication Rates [ Time Frame: Information regarding surgical complications will be collected within 2 days of completion of the subjects surgical procedure. ]
    The number of subjects in each arm that experience a complication during the operative procedure after the initial sedation.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Ability to speak and read in English or Spanish or Haitian Creole
  3. Subjects able to consent for themselves
  4. 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

Exclusion Criteria:

  1. Surgical plan which includes general anesthesia
  2. Hypersensitivity or allergy to benzodiazepines
  3. Women who are pregnant, have a positive pregnancy test on the day of surgery, refuse a pregnancy test, or are nursing
  4. Previous delirium after anesthesia with a benzodiazepine
  5. Subjects 70 years of age or older who fail the delirium pre-screening questionnaire as shown in Appendix Section 15.6
  6. Currently experiencing the effects of drug/alcohol
  7. Current oral/IV regimen of any medication inhibiting cytochrome P450 3A which includes ketoconazole, itraconazole, nefazodone, ritonavir, indinavir, nelavir, saquinavir, and lopinavir
  8. Subjects already enrolled in this study for the fellow eye
  9. Subjects enrolled in a clinical trial with an investigational drug within the past 3 months
  10. Failed anesthesia clearance to receive a benzodiazepine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246724


Contacts
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Contact: Manju Subramanian, MD 617-638-4555 Manju.Subramanian@bmc.org
Contact: Marissa G Fiorello, BS 617-414-8848 Marissa.Fiorello@bmc.org

Locations
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United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Marissa G Fiorello, BS    617-414-8848    Marissa.Fiorello@bmc.org   
Contact: Catherine Villani, BS    617-414-8804    Catherine.Villani@bmc.org   
Principal Investigator: Manju Subramanian, MD         
Sub-Investigator: Nicole Siegel, MD         
Sub-Investigator: Manishi Desai, MD         
Sub-Investigator: Hyunjoo Lee, MD PhD         
Sub-Investigator: Elizabeth Esparaz, MD         
Sub-Investigator: Daniel Luther, MD         
Sub-Investigator: Pavan Sekhar, MD         
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Manju Subramanian, MD Boston Medical Center

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Manju Subramanian, Vice-Chairman of Ophthalmic Clinical Services, Associate Professor, Vitreoretinal Disease and Surgery Attending, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03246724     History of Changes
Other Study ID Numbers: H-36590
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Manju Subramanian, Boston Medical Center:
Ocular surgery
Intravenous sedation
Oral sedation
Additional relevant MeSH terms:
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Midazolam
Triazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action