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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse PONV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone 8mg/IV

Placebo

Sterile normal saline solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo given IV

Interventions

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Dexamethasone

Dexamethasone 8mg/IV

Intervention Type DRUG

Placebo

Placebo given IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No