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Completed

NCT Number: NCT03246724

Oral Versus 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).

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Key information

Conditions

Surgery Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

  • 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

Treatment and study plan

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

Other names: Halcion

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

Other names: Versed

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

Other names: Avicel

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

Other names: Normal Saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. Surgeon Satisfaction

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

    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.

  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. Higher mean scores are associated with higher levels of satisfaction.

Other outcomes

  1. Number of Participants Requiring 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 received 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 experienced a complication during the operative procedure after the initial sedation.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

A Single-center, Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing Oral Sedation to Intravenous Sedation for Ocular Procedures.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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