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

Sponsor

University of Toronto (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01326585

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment	Drug: Dexamethasone Sodium Phosphate Injection Drug: Saline Injection	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2012

Anticipated Study Completion Date :

Apr 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Dexamethasone

Subjects receive intravenous intraoperative dexamethasone

Drug: Dexamethasone Sodium Phosphate Injection

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

Placebo Comparator: Saline solution

Subjects receive intravenous intraoperative normal saline solution

Drug: Saline Injection

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5C 2T2
2	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

University of Toronto

Investigators

Principal Investigator: Mark Mandelcorn, MD FRCSC, University Health Network, Toronto
Principal Investigator: Rajeev Muni, MD FRCSC, Unity Health Toronto
Principal Investigator: Daniel B Rootman, MSc MD, University of Toronto