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

NCT01326585 | Withdrawn Phase 4

• 1 other identifier: 0911-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Retinal Detachment

Keywords

Scleral Buckling; Dexamethasone; Post-operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• Subjective Level of Postoperative Nausea

  Assessed through patient survey, measured by 10cm visual analogue scale

  At 1 and 7 days post-surgery

• Subjective Level of Postoperative Pain

  Assessed by patient survey, measured by Wong-Baker FACES Pain Rating Scale

  1 and 7 days post-surgery

Secondary Outcomes (2)

• Subjective rating of post-operative lid edema

  At 1 and 7 days post-surgery

• Subjective rating of postoperative chemosis

  1 and 7 days post-surgery

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Subjects receive intravenous intraoperative dexamethasone

Drug: Dexamethasone Sodium Phosphate Injection

Saline solution

PLACEBO COMPARATOR

Subjects receive intravenous intraoperative normal saline solution

Drug: Saline Injection

Interventions

Dexamethasone Sodium Phosphate Injection DRUG

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

Dexamethasone

Saline Injection DRUG

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

Saline solution

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-79 years old
• Scheduled for scleral buckle surgery to treat a retinal detachment
• Consent to participate in study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (2)

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Retinal Detachment; Vomiting

Interventions

dexamethasone 21-phosphate; Sodium Chloride

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 31, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 3, 2015

Record last verified: 2011-01

Locations

CA (2)