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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01326585
• Other study ID #: 0911-A
• Status: Withdrawn
• Phase: Phase 4
• First received: March 28, 2011
• Last updated: June 2, 2015
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: January 2011
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Drug:
• Dexamethasone Sodium Phosphate Injection
8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery
• Saline Injection
2cc of 0.9% normal saline, IV injection, 1-time dose during surgery

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Level of Postoperative Nausea	Assessed through patient survey, measured by 10cm visual analogue scale	At 1 and 7 days post-surgery	No
Primary	Subjective Level of Postoperative Pain	Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale	1 and 7 days post-surgery	No
Secondary	Subjective rating of post-operative lid edema	Assessed by investigator, rated "mild", "moderate", or "severe"	At 1 and 7 days post-surgery	No
Secondary	Subjective rating of postoperative chemosis	Assessed by investigator, recorded as "mild", "moderate", or "severe"	1 and 7 days post-surgery	No