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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02073734

Enrollment

Registered

2014-02-27

Start date

2013-02-28

Completion date

2014-08-31

Last updated

2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, PONV

Keywords

pelvic organ prolapse surgery, dexamethasone, postoperative nausea and vomiting, peroperative administration

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.

Interventions

DRUGDexamethasone

Dexamethasone 8mg/IV

DRUGPlacebo

Placebo given IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 81 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026