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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03338400
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.7
• Patients Per Site Per Month: 3.3

Study Details

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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: Aug 21, 2018
• Actual Study Completion Date: Aug 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexamethasone Patients in the Dexamethasone arm will be administered the drug at the time of induction.	Drug: Dexamethasone; 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.

Outcome Measures

Primary Outcome Measures

1. Questionnaire: Quality of Recovery 40 [24 hours]

   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

1. Nausea, Vomiting [24 hrs]

   Clinically important nausea >50

2. Urinary Tract Infections [until 6 weeks]

   Number of UTIs diagnosed in each group

3. Readmissions [6 weeks]

   Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.

4. Pain Level [24 hours]

   numerical pain scale ranges from 0 to 10, where lower scores represent less pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Florida	Weston	Florida	United States	33331

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: G. Willy Davila, Department Head

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 9, 2017

More Information

Publications

None provided.

• Responsible Party: Eric Hurtado, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03338400
• Other Study ID Numbers: FLA17028
• First Posted: Nov 9, 2017
• Last Update Posted: Apr 14, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Eric Hurtado, Principal Investigator, The Cleveland Clinic: Quality of Recovery, Dexamethasone, Same day surgery
• Additional relevant MeSH terms: Uterine Prolapse; Vomiting; Prolapse; Postoperative Nausea and Vomiting; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	Dexamethasone	Normal Saline
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	25	26
COMPLETED	24	24
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Dexamethasone	Normal Saline	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	24	24	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 45.8%	8 33.3%	19 39.6%
>=65 years	13 54.2%	16 66.7%	29 60.4%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66	65	65
Sex: Female, Male (Count of Participants)
Female	24 100%	24 100%	48 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 12.5%	2 8.3%	5 10.4%
Not Hispanic or Latino	20 83.3%	22 91.7%	42 87.5%
Unknown or Not Reported	1 4.2%	0 0%	1 2.1%
Region of Enrollment (participants) [Number]
United States	24 100%	24 100%	48 100%
Body Mass Index (kg/m2) [Mean (Full Range) ]
Mean (Full Range) [kg/m2]	26	28	27

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone	Normal Saline
Arm/Group Description	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.	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.
Measure Participants	24	24
Mean (Standard Deviation) [score on a scale]	174 (14.49)	167 (16.02)

2. Secondary Outcome

Title	Nausea, Vomiting
Description	Clinically important nausea >50
Time Frame	24 hrs

Outcome Measure Data

Analysis Population Description

patients with >50 on nausea scale

Arm/Group Title	Normal Saline	Dexamethasone
Arm/Group Description	Postoperative nausea scale	Postoperative nausea scale
Measure Participants	24	22
Number [participants]	2 8.3%	2 8.3%

3. Secondary Outcome

Title	Urinary Tract Infections
Description	Number of UTIs diagnosed in each group
Time Frame	until 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Saline	Dexamethasone
Arm/Group Description	Number of UTIs	Number of UTIs
Measure Participants	24	22
Number [participants]	1 4.2%	2 8.3%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Number or ER visits post-op

Arm/Group Title	Normal Saline	Dexamethasone
Arm/Group Description	ER visits post-op	ER visits post-op
Measure Participants	24	22
Number [participants]	4 16.7%	1 4.2%

5. Secondary Outcome

Title	Pain Level
Description	numerical pain scale ranges from 0 to 10, where lower scores represent less pain.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

Pain score from 0-10

Arm/Group Title	Normal Saline	Dexamethasone
Arm/Group Description	Postoperative pain scale	Postoperative pain scale
Measure Participants	24	22
Mean (Standard Deviation) [score on a scale]	6.04 (2.8)	4.77 (2.59)

Adverse Events

Time Frame	Adverse event data was collected over 6 month period of time.
Arm/Group Title	Dexamethasone		Normal Saline
Arm/Group Description	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.		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.
All Cause Mortality
	Dexamethasone		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Dexamethasone		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.