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

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

Detailed Description
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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.

Official Title
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Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial

Conditions
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Pelvic Organ Prolapse, PONV

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Dexamethasone | Drug: Dexamethasone<br>* Dexamethasone 8mg/IV<br>|
| Placebo Comparator: Placebo<br>Sterile normal saline solution | Drug: Placebo<br>* Placebo given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). | 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 | up to 20-24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain. |  | 20-24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse surgery, dexamethasone, postoperative nausea and vomiting, peroperative administration