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Completed

NCT Number: NCT02073734

Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP

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

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Key information

Conditions

Pelvic Organ Prolapse Nausea PONV Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Prolapse Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–81 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Triheath

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 8mg/IV

Placebo

Drug

Placebo given IV

Primary outcomes

  1. The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).

    Time frame: up to 20-24 hours after surgery

    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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2014
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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