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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01326585

Enrollment

Registered

2011-03-31

Start date

2011-04-30

Completion date

2012-04-30

Last updated

2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

Scleral Buckling, Dexamethasone, Post-operative Nausea and Vomiting

Brief summary

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.

Interventions

DRUGDexamethasone Sodium Phosphate Injection

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

DRUGSaline Injection

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026