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

Sponsor

TriHealth Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT02073734

Collaborator

(none)

Enrollment

Location

Arms

17.9

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse PONV	Drug: Dexamethasone Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Dexamethasone	Drug: Dexamethasone Dexamethasone 8mg/IV
Placebo Comparator: Placebo Sterile normal saline solution	Drug: Placebo Placebo given IV

Arm

Intervention/Treatment

Experimental: Dexamethasone

Dexamethasone

Drug: Dexamethasone

Dexamethasone 8mg/IV

Placebo Comparator: Placebo

Sterile normal saline solution

Drug: Placebo

Placebo given IV

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 81 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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