Pelvic Organ Prolapse, Prolapses, Vaginal Vault, Quality of Life
Conditions
Keywords
Quality of Recovery, Minimally Invasive Sacrocolpopexy, Dexamethasone
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).
Interventions
DRUGDexamethasone
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.
DRUGNormal 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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| postoperative urinary retention | 6 weeks |
| Infections | 6 weeks |
Countries
United States
Outcome results
None listed