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

NCT ID: NCT03338400

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-08-21

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.

Conditions

Quality of Recovery; Same Day Surgery; Nausea and Vomiting, Postoperative; Vaginal Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dexamethasone

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.

Normal Saline

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.

Interventions

Dexamethasone

Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.

Intervention Type: DRUG

Normal saline

Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Eric Hurtado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

G. Willy Davila

Role: PRINCIPAL_INVESTIGATOR

Department Head

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FLA17028

Identifier Type: -

Identifier Source: org_study_id