Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?

NCT03338400 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FLA17028
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.

Conditions

Quality of Recovery; Same Day Surgery; Nausea and Vomiting, Postoperative; Vaginal Prolapse

Keywords

Quality of Recovery, Dexamethasone, Same day surgery

Outcome Measures

Primary Outcomes (1)

• Questionnaire: Quality of Recovery 40

  The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively.

  24 hours

Secondary Outcomes (4)

• Nausea, Vomiting

  24 hrs

• Urinary Tract Infections

  until 6 weeks

• Readmissions

  6 weeks

• Pain Level

  24 hours

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Patients in the Dexamethasone arm will be administered the drug at the time of induction.

Drug: Dexamethasone

Normal Saline

PLACEBO COMPARATOR

The placebo arm patients will receive normal saline at the time of induction.

Drug: Normal saline

Interventions

Dexamethasone DRUG

Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.

Dexamethasone

Normal saline DRUG

Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The surgeries that are performed are only vaginal prolapse surgeries in a female pelvic medicine and reconstructive surgery department.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over the age of 18
• Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy
• ASA class 1-2

You may not qualify if:

• Daily use of steroids, antiemetics in the month prior to surgery
• Chronic pain requiring daily opioid treatment
• History of allergy/intolerance to Dexamethasone
• ASA class 3
• Numerical Pain score of more than 4 at baseline
• Renal/Liver disease
• Diabetes mellitus
• Pregnancy
• Inability to answer questionnaires
• Any systemic infections
• Immuno compromised status
• Patients with planned overnight stay

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Uterine Prolapse

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. David Ossin
• Organization: Cleveland Clinic Florida

ossind@ccf.org

954-659-5559

Study Officials

• G. Willy Davila

  Department Head

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 9, 2017
• Study Start: May 1, 2017
• Primary Completion: August 21, 2018
• Study Completion: August 21, 2018
• Last Updated: April 14, 2021
• Results First Posted: May 10, 2019

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)