NCT03094442

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Dexamethasone	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.
DRUG	Normal saline	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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-03-29
• Last updated: 2020-02-05

Locations

1 site across 1 country: United States