Back to resultsStudy Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery
Primary Purpose
Retinal Detachment
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone Sodium Phosphate Injection
Saline Injection
Sponsored by
About this trial
This is an interventional supportive care trial for Retinal Detachment focused on measuring Scleral Buckling, Dexamethasone, Post-operative Nausea and Vomiting
Eligibility Criteria
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
Sites / Locations
- St. Michael's Hospital
- Toronto Western Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
Saline solution
Arm Description
Subjects receive intravenous intraoperative dexamethasone
Subjects receive intravenous intraoperative normal saline solution
Outcomes
Primary Outcome Measures
Subjective Level of Postoperative Nausea
Assessed through patient survey, measured by 10cm visual analogue scale
Subjective Level of Postoperative Pain
Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale
Secondary Outcome Measures
Subjective rating of post-operative lid edema
Assessed by investigator, rated "mild", "moderate", or "severe"
Subjective rating of postoperative chemosis
Assessed by investigator, recorded as "mild", "moderate", or "severe"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01326585
Brief Title
Study Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery
Official Title
Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
Scleral Buckling, Dexamethasone, Post-operative Nausea and Vomiting
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Subjects receive intravenous intraoperative dexamethasone
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Subjects receive intravenous intraoperative normal saline solution
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Sodium Phosphate Injection
Intervention Description
8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery
Intervention Type
Drug
Intervention Name(s)
Saline Injection
Intervention Description
2cc of 0.9% normal saline, IV injection, 1-time dose during surgery
Primary Outcome Measure Information:
Title
Subjective Level of Postoperative Nausea
Description
Assessed through patient survey, measured by 10cm visual analogue scale
Time Frame
At 1 and 7 days post-surgery
Title
Subjective Level of Postoperative Pain
Description
Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale
Time Frame
1 and 7 days post-surgery
Secondary Outcome Measure Information:
Title
Subjective rating of post-operative lid edema
Description
Assessed by investigator, rated "mild", "moderate", or "severe"
Time Frame
At 1 and 7 days post-surgery
Title
Subjective rating of postoperative chemosis
Description
Assessed by investigator, recorded as "mild", "moderate", or "severe"
Time Frame
1 and 7 days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mandelcorn, MD FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajeev Muni, MD FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel B Rootman, MSc MD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery
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