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Oral Sedation in Vitreoretinal Surgery

NCT04346095 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-04-15

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.

Conditions

  • Macular Holes
  • Intraocular Lens Opacification
  • Vitrectomy
  • Vitreous Hemorrhage
  • Retinal Detachment
  • Epiretinal Membrane
  • Vitreous Detachment
  • Intraocular Lens Dislocation

Interventions

DRUG

Oral Sedatives with or Without Analgesia

The participants will receive oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.

DRUG

Intravenous Sedatives with or Without Analgesia

The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.

Sponsors & Collaborators

  • Rocky Vista University, LLC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2020-10-31
Completion
2020-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346095 on ClinicalTrials.gov