NCT02073734

Brief Summary

The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

April 25, 2013

Last Update Submit

April 19, 2016

Conditions

Pelvic Organ ProlapsePONV

Keywords

pelvic organ prolapse surgerydexamethasonepostoperative nausea and vomitingperoperative administration

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 20-24 hours after surgery

Secondary Outcomes (1)

  • To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.

    20-24 hours after surgery

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Sterile normal saline solution

Drug: Placebo

Interventions

DexamethasoneDRUG

Dexamethasone 8mg/IV

Dexamethasone
PlaceboDRUG

Placebo given IV

Placebo

Eligibility Criteria

Age18 Years - 81 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Triheath

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • 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.

    PMID: 26032041DERIVED

MeSH Terms

Conditions

Pelvic Organ ProlapsePostoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Rachel N Pauls, MD

    TriHealth Good Samaritan Hospital

    STUDY DIRECTOR

  • Rachel N Pauls, MD

    TriHeath Good Samaritan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2013

First Posted

February 27, 2014

Study Start

February 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)