Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP

Completed · Phase 3 · Has a placebo group

Conditions studied: Pelvic Organ Prolapse, PONV

In brief

The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.

Key facts

Study ID

NCT02073734

Run by

TriHealth Inc.

People needed

63

Starts

2013-02-01

Expected to finish

2014-08-01

Last updated by the study team

2016-04-21

Who can join

Age: 18 and older, up to 81. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy

You may not qualify if…

• Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
• Regional anesthesia for surgical procedure
• Chronic pain requiring opioid treatment daily
• History of allergy to the study medication
• Severe renal and liver disease
• Pregnancy
• Non English speaking
• Psychiatric disorder that will preclude completion of questionnaires
• Minor surgery that does not involve overnight admission
• Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
• Hypersensitivity reaction to steroids
• Evidence of systemic fungal infection
• Evidence of any systemic infection
• Uncontrolled diabetes

Where it is running

• Triheath — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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