Study Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-04-30

Brief Summary

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Dexamethasone is a medication that has been shown to have clear anti-nausea, anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage postoperative symptoms of a variety of surgical procedures. However, its effect has not been validated for scleral buckling surgery, which is used to treat retinal detachment, a medical emergency that can lead to permanent blindness. In this study, the investigators will randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo to the other half. The investigators will then compare the postoperative symptoms of the two groups in order to determine whether dexamethasone should be used for scleral buckling surgeries.

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Detailed Description

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Conditions

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Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexamethasone

Subjects receive intravenous intraoperative dexamethasone

Group Type EXPERIMENTAL

Dexamethasone Sodium Phosphate Injection

Intervention Type DRUG

8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery

Saline solution

Subjects receive intravenous intraoperative normal saline solution

Group Type PLACEBO_COMPARATOR

Saline Injection

Intervention Type DRUG

2cc of 0.9% normal saline, IV injection, 1-time dose during surgery

Interventions

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Dexamethasone Sodium Phosphate Injection

8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery

Intervention Type DRUG

Saline Injection

2cc of 0.9% normal saline, IV injection, 1-time dose during surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-79 years old
* Scheduled for scleral buckle surgery to treat a retinal detachment
* Consent to participate in study

Exclusion Criteria

* Pregnant or nursing
* Prior treatment with steroids
* Severe diabetes mellitus (HbA1c \> 8%)
* Use of opioids, sedatives, or any kind of analgesics \<1 week before scleral buckling surgery
* History of alcohol or drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No