Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Dexamethasone
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- TriHealth Inc.
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.
Detailed Description
This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.
Investigators
Eligibility 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
Arms & Interventions
Dexamethasone
Dexamethasone
Intervention: Dexamethasone
Placebo
Sterile normal saline solution
Intervention: Placebo
Outcomes
Primary Outcomes
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
Time Frame: up to 20-24 hours after surgery
The QoR-40 is a validated standardized questionnaire that assesses the dimensions of physical functioning, mental health, cognitive functioning, symptoms, role and social functioning, general health perceptions, sleep and energy
Secondary Outcomes
- To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.(20-24 hours after surgery)