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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03094442
• Other study ID #: FLA 16-081
• Status: Withdrawn
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative urinary retention		6 weeks
Other	Infections		6 weeks
Primary	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	Numerical Pain Scale	Pain at baseline, 24 hours and 6 weeks will be recorded.	baseline, 24 hours, 6 weeks
Secondary	Postoperative Nausea Vomiting Scale	Immediate nausea and vomiting 24 hours after surgery. Use of rescue antiemetics will be recorded	6 weeks