Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
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|ClinicalTrials.gov Identifier: NCT03338400|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Quality of Recovery Same Day Surgery Nausea and Vomiting, Postoperative Vaginal Prolapse||Drug: Dexamethasone Drug: Normal saline||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Active Comparator: Dexamethasone
Patients in the Dexamethasone arm will be administered the drug at the time of induction.
Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.
Placebo Comparator: Normal Saline
The placebo arm patients will receive normal saline at the time of induction.
Drug: Normal saline
Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
- Questionnaire: Quality of Recovery 40 [ Time Frame: 24 hours, 6 weeks ]The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved QoR. This would be measured using the Quality of Recovery 40 questionnaire.
- Nausea, Vomiting [ Time Frame: 24 hrs ]Patients will be administered a postoperative nausea, vomiting scale. The "Post Operative Nausea Scale" ranges from 0 to 77, where lower scores are improved outcomes.
- Urinary tract infections [ Time Frame: until 6 weeks ]
- readmissions [ Time Frame: 6 weeks ]Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.
- Pain level [ Time Frame: 24 hours ]numerical pain scale ranges from 0 to 10, where lower scores represent less pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338400
|Contact: Jeffrey Schachar, MDfirstname.lastname@example.org|
|Contact: Bridget Howardemail@example.com|
|United States, Florida|
|Cleveland Clinic Florida||Recruiting|
|Weston, Florida, United States, 33331|
|Contact: Jeffrey Schachar, MD|
|Principal Investigator:||G. Willy Davila||Department Head|