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To the investigators knowledge there are no studies in the literature evaluating the effect 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator | Patients in the Dexamethasone arm will be administered the drug at the time of induction. |
|
| Normal Saline | Placebo Comparator | The placebo arm patients will receive normal saline at the time of induction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire: Quality of Recovery 40 | 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 Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea, Vomiting | Clinically important nausea >50 | 24 hrs |
| Urinary Tract Infections | Number of UTIs diagnosed in each group | until 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The surgeries that are performed are only vaginal prolapse surgeries in a female pelvic medicine and reconstructive surgery department.
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| Name | Affiliation | Role |
|---|---|---|
| G. Willy Davila | Department Head | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction. |
| FG001 | Normal Saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2017 |
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| Normal saline | Drug | Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction. |
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| Readmissions | Any patient that is re-admitted to the hospital and the reason for re-admission will be collected. | 6 weeks |
| Pain Level | numerical pain scale ranges from 0 to 10, where lower scores represent less pain. | 24 hours |
The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction. |
| BG001 | Normal Saline | The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body Mass Index | Mean | Full Range | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Questionnaire: Quality of Recovery 40 | 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 Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
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| Secondary | Nausea, Vomiting | Clinically important nausea >50 | patients with >50 on nausea scale | Posted | Number | participants | 24 hrs |
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| Secondary | Urinary Tract Infections | Number of UTIs diagnosed in each group | Posted | Number | participants | until 6 weeks |
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| Secondary | Readmissions | Any patient that is re-admitted to the hospital and the reason for re-admission will be collected. | Number or ER visits post-op | Posted | Number | participants | 6 weeks |
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| ||||||||||||||||||||||||||||||
| Secondary | Pain Level | numerical pain scale ranges from 0 to 10, where lower scores represent less pain. | Pain score from 0-10 | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
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Adverse event data was collected over 6 month period of time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | Patients in the Dexamethasone arm will be administered the drug at the time of induction. Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Normal Saline | The placebo arm patients will receive normal saline at the time of induction. Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction. | 0 | 24 | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Ossin | Cleveland Clinic Florida | 954-659-5559 | ossind@ccf.org |
| Aug 21, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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