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

Phase 3

Completed

• Conditions: Pelvic Organ Prolapse; PONV
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT02073734
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-27
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sterile normal saline solution
Dexamethasone	Dexamethasone	Dexamethasone

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).	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 Outcome Measures

Name	Time	Method
To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.	20-24 hours after surgery

Trial Locations

Locations (1)

Triheath; 🇺🇸 Cincinnati, Ohio, United States