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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03094442
Other study ID # FLA 16-081
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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