Clinical trial NCT03338400: Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
Official title: Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Quality of Recovery
Same Day Surgery
Nausea and Vomiting, Postoperative
Vaginal Prolapse
Keywords: Quality of Recovery, Dexamethasone, Same day surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The lifetime risk of undergoing surgical intervention for pelvic organ prolapse (POP) is estimated to be 10% and it is projected that from 2010 to 2050, the number of surgeries for POP will rise by 47.2%, from 166,000 to 245,970. In 1980, accounting for the rising costs of health care, congress approved Medicare to reimburse procedures performed at outpatient and ambulatory surgery centers. This led to an increasing number of stress incontinence (SUI) procedures being performed in the ambulatory setting from 34,968 in 1996 to 105,656 in 2006. However, the number of ambulatory POP surgeries decreased in the same time period. This was possibly due to the increase in the mean age of women undergoing ambulatory procedures for POP and SUI during that time periods.

At the investigator's institution has performed outpatient surgeries for POP and SUI for the past 3 years. Patients have tolerated same day surgery with minimal complications. In the investigator's previous prospective study assessing satisfaction after outpatient surgeries for POP and SUI, patients had a decreased quality of recovery at 48 hours compared to baseline. The investigators also recognized that nausea and pain control could have been better addressed. Unpleasant postoperative nausea and vomiting, pain control, return to normal voiding and return of bowel function can influence the quality of recovery (QOR) from surgery.

Postoperative nausea and vomiting (PONV) and pain management are particularly troubling for the patients. This might also delay discharge and prolong convalescence from the surgery.

Several safe interventions have been assessed in the literature for alleviating PONV, pain and recovery from laparoscopic gynecologic surgery.

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 hamper the production and release of anti-inflammatory mediators, thereby decreasing postoperative nausea, emesis, pain perception and 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.

Pauls et al in their recent study randomized patients undergoing vaginal prolapse surgery to receive Dexamethasone and noted a decrease in PONV and reduced requirement of a rescue antiemetic. Their model involved patients with overnight stay and the results may not be applicable to our population. They also noted that women who received Dexamethasone preoperatively were more likely to pass the voiding trial.

Eligibility criteria: Inclusion Criteria:

1. Women over the age of 18
2. Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy
3. 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 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
12. Patients with planned overnight stay

Primary outcomes:
measure: Questionnaire: Quality of Recovery 40
timeFrame: 24 hours
Secondary outcomes:
measure: Nausea, Vomiting
timeFrame: 24 hrs
measure: Urinary Tract Infections
timeFrame: until 6 weeks
measure: Readmissions
timeFrame: 6 weeks
measure: Pain Level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Department Head
name: G. Willy Davila
role: PRINCIPAL_INVESTIGATOR
References: