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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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