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

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TriHealth

Status and phase

Completed
Phase 3

Conditions

PONV
Pelvic Organ Prolapse

Treatments

Drug: Placebo
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT02073734
12136-12-081

Details and patient eligibility

About

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

Full 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.

Enrollment

63 patients

Sex

Female

Ages

18 to 81 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

63 participants in 2 patient groups, including a placebo group

Dexamethasone
Experimental group
Description:
Dexamethasone
Treatment:
Drug: Dexamethasone
Placebo
Placebo Comparator group
Description:
Sterile normal saline solution
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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