Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

Study Overview
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Brief Summary
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The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery (QoR).

Detailed Description
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There has been a public outcry regarding the continuing rise of health care expenditures. In 1997, the estimated costs of surgery for pelvic organ prolapse (POP) were $ 100.1 million. It is important to identify interventions that would improve the QoR in this patient population and to speed-up postoperative recovery. As most of these surgeries are performed in an outpatient manner as a 23 hour observation, improved recovery may also speed discharge and free-up valuable hospital resources. Patients will receive either Dexamethasone or placebo ( normal saline) at the time of induction of general anesthesia. QoR questionnaires, Pain scale and postoperative nausea and vomiting scale (PONV).

Official Title
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Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

Conditions
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Pelvic Organ Prolapse, Prolapses, Vaginal Vault, Quality of Life

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over the age of 18 Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy American Society of Anesthesiologists (ASA) class 1-2 Exclusion Criteria: Daily use of steroids, antiemetics in the month prior to surgery Chronic pain requiring daily opioid treatment History of allergy/intolerance to Dexamethasone ASA class 3 Numerical Pain score (NPS) of more than 4 at baseline Renal/Liver disease Diabetes mellitus Pregnancy Inability to answer questionnaires Any systemic infections Immuno compromised status

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Dexamethasone is a potent corticosteroid that has been widely used for chemotherapy induced nausea and vomiting. The mechanism of action is not completely understood. It has been proposed that a single dose may hinder the production and release of anti-inflammatory mediators. Dexamethasone also has a central antiemetic effect by inhibition of prostaglandin and/or release of endogenous opioids. A recent metanalysis concluded that Dexamethasone administration at induction is safe. We will be using a 8mg dose of Dexamethasone, that is equivalent to 2ml of injectable drug. | Drug: Dexamethasone<br>* An 8 mg dose of Dexamethasone is administered at the time of induction of general anesthesia. The medication is provided by the pharmacy in a blinded syringe.<br>* Other names: Steroid;|
| Placebo Comparator: Saline<br>Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy. | Drug: Normal saline<br>* Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery 40 (QoR-40) | Quality of Recovery 40 will be recorded at baseline, 24 hours and 6 weeks. The change in the mean scores will be computed for each group. The primary endpoint of change in QoR from baseline will be analyzed through t- test. | baseline, 24 hours, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Scale | Pain at baseline, 24 hours and 6 weeks will be recorded. | baseline, 24 hours, 6 weeks | 
| Postoperative Nausea Vomiting Scale | Immediate nausea and vomiting 24 hours after surgery. Use of rescue antiemetics will be recorded | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Recovery, Minimally Invasive Sacrocolpopexy, Dexamethasone