Phase 2
N=51
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
Quality of Recovery · Same Day Surgery · Nausea and Vomiting, Postoperative · Vaginal Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT03338400 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Questionnaire: Quality of Recovery 40 — 174; 167 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexamethasone (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Questionnaire: Quality of Recovery 40 |
174; 167 | — |
| SECONDARY Nausea, Vomiting |
2; 2 | — |
| SECONDARY Urinary Tract Infections |
1; 2 | — |
| SECONDARY Readmissions |
4; 1 | — |
| SECONDARY Pain Level |
6.04; 4.77 | — |
Summary
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
Eligibility Criteria
Inclusion Criteria
- Women over the age of 18
- Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy
- ASA class 1-2
Exclusion Criteria
- Daily use of steroids, antiemetics in the month prior to surgery
- Chronic pain requiring daily opioid treatment
- History of allergy/intolerance to Dexamethasone
- ASA class 3
- Numerical Pain score of more than 4 at baseline
- Renal/Liver disease
- Diabetes mellitus
- Pregnancy
- Inability to answer questionnaires
- Any systemic infections
- Immuno compromised status
- Patients with planned overnight stay
Data sourced from ClinicalTrials.gov (NCT03338400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.