Back to resultsEffects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
Primary Purpose
Pelvic Organ Prolapse, PONV
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse surgery, dexamethasone, postoperative nausea and vomiting, peroperative administration
Eligibility Criteria
Inclusion Criteria:
- Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy
Exclusion Criteria:
- Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
- Regional anesthesia for surgical procedure
- Chronic pain requiring opioid treatment daily
- History of allergy to the study medication
- Severe renal and liver disease
- Pregnancy
- Non English speaking
- Psychiatric disorder that will preclude completion of questionnaires
- Minor surgery that does not involve overnight admission
- Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
- Hypersensitivity reaction to steroids
- Evidence of systemic fungal infection
- Evidence of any systemic infection
- Uncontrolled diabetes
Sites / Locations
- Triheath
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
Placebo
Arm Description
Dexamethasone
Sterile normal saline solution
Outcomes
Primary Outcome Measures
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
The QoR-40 is a validated standardized questionnaire that assesses the dimensions of physical functioning, mental health, cognitive functioning, symptoms, role and social functioning, general health perceptions, sleep and energy
Secondary Outcome Measures
To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02073734
Brief Title
Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
Official Title
Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.
Detailed Description
This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, PONV
Keywords
pelvic organ prolapse surgery, dexamethasone, postoperative nausea and vomiting, peroperative administration
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile normal saline solution
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 8mg/IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given IV
Primary Outcome Measure Information:
Title
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
Description
The QoR-40 is a validated standardized questionnaire that assesses the dimensions of physical functioning, mental health, cognitive functioning, symptoms, role and social functioning, general health perceptions, sleep and energy
Time Frame
up to 20-24 hours after surgery
Secondary Outcome Measure Information:
Title
To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.
Time Frame
20-24 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy
Exclusion Criteria:
Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
Regional anesthesia for surgical procedure
Chronic pain requiring opioid treatment daily
History of allergy to the study medication
Severe renal and liver disease
Pregnancy
Non English speaking
Psychiatric disorder that will preclude completion of questionnaires
Minor surgery that does not involve overnight admission
Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
Hypersensitivity reaction to steroids
Evidence of systemic fungal infection
Evidence of any systemic infection
Uncontrolled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel N Pauls, MD
Organizational Affiliation
TriHealth Good Samaritan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rachel N Pauls, MD
Organizational Affiliation
TriHeath Good Samaritan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Triheath
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26032041
Citation
Pauls RN, Crisp CC, Oakley SH, Westermann LB, Mazloomdoost D, Kleeman SD, Ghodsi V, Estanol MV. Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial. Am J Obstet Gynecol. 2015 Nov;213(5):718.e1-7. doi: 10.1016/j.ajog.2015.05.061. Epub 2015 May 29.
Results Reference
derived
Learn more about this trial
Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
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