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
  Purpose

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 Intervention Phase
Retinal Detachment
Drug: Dexamethasone Sodium Phosphate Injection
Drug: Saline Injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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"


Estimated Enrollment: 82
Study Start Date: April 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326585

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

Locations
Canada, Ontario
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Mark Mandelcorn, MD FRCSC    416-603-5885    mark.mandelcorn@utoronto.ca   
Principal Investigator: Mark Mandelcorn, MD FRCSC         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: Rajeev Muni, MD FRCSC    416-867-7411    rajeev.muni@utoronto.ca   
Principal Investigator: Rajeev Muni, MD FRCSC         
Sponsors and Collaborators
University of Toronto
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Mark Mandelcorn, University Health Network
ClinicalTrials.gov Identifier: NCT01326585     History of Changes
Other Study ID Numbers: 0911-A
Study First Received: March 28, 2011
Last Updated: September 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Scleral Buckling
Dexamethasone
Post-operative Nausea and Vomiting

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014