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

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).

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life; Pelvic Organ Prolapse; Prolapses, Vaginal Vault
• Intervention / Treatment: Drug: Dexamethasone; Drug: Normal saline

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33326
      • Cleveland Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Steroid
Placebo Comparator: 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.	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.; Other Names: Placebo

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
postoperative urinary retention	6 weeks
Infections	6 weeks

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: David Ossin, MD, Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Dexamethasone; Quality of Recovery; Minimally Invasive Sacrocolpopexy
• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Uterine Prolapse; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: FLA 16-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO