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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073734
• Other study ID #: 12136-12-081
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2013
• Last updated: April 19, 2016
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: April 2016
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 81 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• PONV
• Prolapse

Intervention

Drug:
• Dexamethasone
Dexamethasone 8mg/IV
• Placebo
Placebo given IV

Locations

Country	Name	City	State
United States	Triheath	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.		20-24 hours after surgery	No