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

NeuroTherapia, Inc.

Status: Withdrawn

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

Treatments: Drug: Dexamethasone; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03094442

FLA 16-081

Details and patient eligibility

About

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).

Full description

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).

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women over the age of 18
2. Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy
3. American Society of Anesthesiologists (ASA) class 1-2

Exclusion criteria

1. Daily use of steroids, antiemetics in the month prior to surgery
2. Chronic pain requiring daily opioid treatment
3. History of allergy/intolerance to Dexamethasone
4. ASA class 3
5. Numerical Pain score (NPS) of more than 4 at baseline
6. Renal/Liver disease
7. Diabetes mellitus
8. Pregnancy
9. Inability to answer questionnaires
10. Any systemic infections
11. Immuno compromised status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone

Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline