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

Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelvic Organ Prolapse; PONV

Intervention: Dexamethasone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: TriHealth Inc.

Official(s) and/or principal investigator(s):
Rachel N Pauls, MD, Study Director, Affiliation: TriHealth Good Samaritan Hospital
Rachel N Pauls, MD, Principal Investigator, Affiliation: TriHeath Good Samaritan Hospital

Summary

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

Clinical Details

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

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

Primary outcome: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).

Secondary outcome: To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 81 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Triheath, Cincinnati, Ohio 45220, United States
Additional Information

Starting date: February 2013
Last updated: October 15, 2014

Page last updated: August 23, 2015

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