Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/11/2017 |
| Start Date: | May 1, 2017 |
| End Date: | December 31, 2018 |
| Contact: | Jeffrey Schachar, MD |
| Email: | schachj@ccf.org |
| Phone: | 9546595559 |
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?
To the investigators knowledge there are no studies in the literature evaluating the effect
of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
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.
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.
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
We found this trial at
1
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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