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

Study Overview
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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.

Official Title
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Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial

Conditions
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Retinal Detachment

Intervention / Treatment
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* Drug: Dexamethasone Sodium Phosphate Injection
* Drug: Saline Injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Subjects receive intravenous intraoperative dexamethasone | Drug: Dexamethasone Sodium Phosphate Injection<br>* 8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery<br>|
| Placebo Comparator: Saline solution<br>Subjects receive intravenous intraoperative normal saline solution | Drug: Saline Injection<br>* 2cc of 0.9% normal saline, IV injection, 1-time dose during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Level of Postoperative Nausea | Assessed through patient survey, measured by 10cm visual analogue scale | At 1 and 7 days post-surgery | 
| Subjective Level of Postoperative Pain | Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale | 1 and 7 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective rating of post-operative lid edema | Assessed by investigator, rated mild, moderate, or severe | At 1 and 7 days post-surgery | 
| Subjective rating of postoperative chemosis | Assessed by investigator, recorded as mild, moderate, or severe | 1 and 7 days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scleral Buckling, Dexamethasone, Post-operative Nausea and Vomiting