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Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

Primary Purpose

Quality of Life, Pelvic Organ Prolapse, Prolapses, Vaginal Vault

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Normal saline

Sponsored by

The Cleveland Clinic

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Quality of Recovery, Minimally Invasive Sacrocolpopexy, Dexamethasone

Eligibility Criteria

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

Inclusion Criteria:

Women over the age of 18
Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy
American Society of Anesthesiologists (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 (NPS) of more than 4 at baseline
Renal/Liver disease
Diabetes mellitus
Pregnancy
Inability to answer questionnaires
Any systemic infections
Immuno compromised status

Sites / Locations

Cleveland Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Saline

Arm Description

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 hinder the production and release of anti-inflammatory mediators. 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. We will be using a 8mg dose of Dexamethasone, that is equivalent to 2ml of injectable drug.

Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.

Outcomes

Primary Outcome Measures

Quality of recovery 40 (QoR-40)

Quality of Recovery 40 will be recorded at baseline, 24 hours and 6 weeks. The change in the mean scores will be computed for each group. The primary endpoint of change in QoR from baseline will be analyzed through t- test.

Secondary Outcome Measures

Numerical Pain Scale

Pain at baseline, 24 hours and 6 weeks will be recorded.

Postoperative Nausea Vomiting Scale

Immediate nausea and vomiting 24 hours after surgery. Use of rescue antiemetics will be recorded

Full Information

NCT ID

First Posted

February 20, 2017

Last Updated

February 4, 2020

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03094442

Brief Title

Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

Official Title

Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Withdrawn

Study Start Date

December 2016 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery (QoR).

Detailed Description

There has been a public outcry regarding the continuing rise of health care expenditures. In 1997, the estimated costs of surgery for pelvic organ prolapse (POP) were $ 100.1 million. It is important to identify interventions that would improve the QoR in this patient population and to speed-up postoperative recovery. As most of these surgeries are performed in an outpatient manner as a 23 hour observation, improved recovery may also speed discharge and free-up valuable hospital resources. Patients will receive either Dexamethasone or placebo ( normal saline) at the time of induction of general anesthesia. QoR questionnaires, Pain scale and postoperative nausea and vomiting scale (PONV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Quality of Life, Pelvic Organ Prolapse, Prolapses, Vaginal Vault

Keywords

Quality of Recovery, Minimally Invasive Sacrocolpopexy, Dexamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

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 hinder the production and release of anti-inflammatory mediators. 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. We will be using a 8mg dose of Dexamethasone, that is equivalent to 2ml of injectable drug.

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Steroid

Intervention Description

An 8 mg dose of Dexamethasone is administered at the time of induction of general anesthesia. The medication is provided by the pharmacy in a blinded syringe.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

Placebo

Intervention Description

Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.

Primary Outcome Measure Information:

Title

Quality of recovery 40 (QoR-40)

Description

Quality of Recovery 40 will be recorded at baseline, 24 hours and 6 weeks. The change in the mean scores will be computed for each group. The primary endpoint of change in QoR from baseline will be analyzed through t- test.

Time Frame

baseline, 24 hours, 6 weeks

Secondary Outcome Measure Information:

Title

Numerical Pain Scale

Description

Pain at baseline, 24 hours and 6 weeks will be recorded.

Time Frame

baseline, 24 hours, 6 weeks

Title

Postoperative Nausea Vomiting Scale

Description

Immediate nausea and vomiting 24 hours after surgery. Use of rescue antiemetics will be recorded

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

postoperative urinary retention

Time Frame

6 weeks

Title

Infections

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Women over the age of 18 Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy American Society of Anesthesiologists (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 (NPS) of more than 4 at baseline Renal/Liver disease Diabetes mellitus Pregnancy Inability to answer questionnaires Any systemic infections Immuno compromised status

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Ossin, MD

Organizational Affiliation

Cleveland Clinic Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Florida

City

Weston

State/Province

Florida

ZIP/Postal Code

33326

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

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Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

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