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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by University of Toronto.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

University of Toronto

ClinicalTrials.gov Identifier:

NCT01326585

First received: March 28, 2011

Last updated: September 14, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 28, 2011

Last Updated Date

September 14, 2011

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Subjective Level of Postoperative Nausea [ Time Frame: At 1 and 7 days post-surgery ] [ Designated as safety issue: No ]
Assessed through patient survey, measured by 10cm visual analogue scale
Subjective Level of Postoperative Pain [ Time Frame: 1 and 7 days post-surgery ] [ Designated as safety issue: No ]
Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01326585 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjective rating of post-operative lid edema [ Time Frame: At 1 and 7 days post-surgery ] [ Designated as safety issue: No ]
Assessed by investigator, rated "mild", "moderate", or "severe"
Subjective rating of postoperative chemosis [ Time Frame: 1 and 7 days post-surgery ] [ Designated as safety issue: No ]
Assessed by investigator, recorded as "mild", "moderate", or "severe"

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Retinal Detachment

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Dexamethasone
Subjects receive intravenous intraoperative dexamethasone

Intervention: Drug: Dexamethasone Sodium Phosphate Injection
Placebo Comparator: Saline solution
Subjects receive intravenous intraoperative normal saline solution

Intervention: Drug: Saline Injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mark Mandelcorn, MD FRCSC	416-603-5885	mark.mandelcorn@utoronto.ca
Contact: Daniel B Rootman, MSc MD		dan.rootman@gmail.com

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01326585

Other Study ID Numbers ^ICMJE

0911-A

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Mark Mandelcorn, University Health Network

Study Sponsor ^ICMJE

University of Toronto

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Mark Mandelcorn, MD FRCSC	University Health Network, Toronto
Principal Investigator:	Rajeev Muni, MD FRCSC	St. Michael's Hospital, Toronto
Principal Investigator:	Daniel B Rootman, MSc MD	University of Toronto

Information Provided By

University of Toronto

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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