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

Not Applicable

Withdrawn

• Conditions: Quality of Life; Pelvic Organ Prolapse; Prolapses, Vaginal Vault
• Interventions: Drug: Normal saline; Drug: Dexamethasone

• Registration Number: NCT03094442
• Lead Sponsor: The Cleveland Clinic

Brief 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).

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	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.
Dexamethasone	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Quality of recovery 40 (QoR-40)	baseline, 24 hours, 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Numerical Pain Scale	baseline, 24 hours, 6 weeks	Pain at baseline, 24 hours and 6 weeks will be recorded.
Postoperative Nausea Vomiting Scale	6 weeks	Immediate nausea and vomiting 24 hours after surgery. Use of rescue antiemetics will be recorded

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States