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Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?

Primary Purpose

Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Normal saline
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Recovery focused on measuring Quality of Recovery, Dexamethasone, Same day surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Normal Saline

Arm Description

Patients in the Dexamethasone arm will be administered the drug at the time of induction.

The placebo arm patients will receive normal saline at the time of induction.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Nausea, Vomiting
Clinically important nausea >50
Urinary Tract Infections
Number of UTIs diagnosed in each group
Readmissions
Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.
Pain Level
numerical pain scale ranges from 0 to 10, where lower scores represent less pain.

Full Information

First Posted
October 20, 2017
Last Updated
March 21, 2021
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03338400
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative, Vaginal Prolapse
Keywords
Quality of Recovery, Dexamethasone, Same day surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Patients in the Dexamethasone arm will be administered the drug at the time of induction.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
The placebo arm patients will receive normal saline at the time of induction.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Primary Outcome Measure Information:
Title
Questionnaire: Quality of Recovery 40
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Nausea, Vomiting
Description
Clinically important nausea >50
Time Frame
24 hrs
Title
Urinary Tract Infections
Description
Number of UTIs diagnosed in each group
Time Frame
until 6 weeks
Title
Readmissions
Description
Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.
Time Frame
6 weeks
Title
Pain Level
Description
numerical pain scale ranges from 0 to 10, where lower scores represent less pain.
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The surgeries that are performed are only vaginal prolapse surgeries in a female pelvic medicine and reconstructive surgery department.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women over the age of 18 Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy ASA class 1-2 Exclusion Criteria: Daily use of steroids, antiemetics in the month prior to surgery Chronic pain requiring daily opioid treatment History of allergy/intolerance to Dexamethasone ASA class 3 Numerical Pain score of more than 4 at baseline Renal/Liver disease Diabetes mellitus Pregnancy Inability to answer questionnaires Any systemic infections Immuno compromised status Patients with planned overnight stay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Willy Davila
Organizational Affiliation
Department Head
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?

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