Does Dexamethasone Administration Improve Recovery In Patients Undergoing Minimally Invasive Sacrocolpopexy?

NCT03094442 | Withdrawn DMC

• 1 other identifier: FLA 16-081
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to evaluate whether standard administration of Dexamethasone at the time of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would result in improved quality of recovery (QoR).

Conditions

Quality of Life; Pelvic Organ Prolapse; Prolapses, Vaginal Vault

Keywords

Quality of Recovery; Minimally Invasive Sacrocolpopexy; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Quality of recovery 40 (QoR-40)

  Quality of Recovery 40 will be recorded at baseline, 24 hours and 6 weeks. The change in the mean scores will be computed for each group. The primary endpoint of change in QoR from baseline will be analyzed through t- test.

  baseline, 24 hours, 6 weeks

Secondary Outcomes (2)

• Numerical Pain Scale

  baseline, 24 hours, 6 weeks

• Postoperative Nausea Vomiting Scale

  6 weeks

Other Outcomes (2)

• postoperative urinary retention

  6 weeks

• Infections

  6 weeks

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone is a potent corticosteroid that has been widely used for chemotherapy induced nausea and vomiting. The mechanism of action is not completely understood. It has been proposed that a single dose may hinder the production and release of anti-inflammatory mediators. Dexamethasone also has a central antiemetic effect by inhibition of prostaglandin and/or release of endogenous opioids. A recent metanalysis concluded that Dexamethasone administration at induction is safe. We will be using a 8mg dose of Dexamethasone, that is equivalent to 2ml of injectable drug.

Drug: Dexamethasone

Saline

PLACEBO COMPARATOR

Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.

Drug: Normal saline

Interventions

Dexamethasone DRUG

An 8 mg dose of Dexamethasone is administered at the time of induction of general anesthesia. The medication is provided by the pharmacy in a blinded syringe.

Also known as: Steroid

Dexamethasone

Normal saline DRUG

Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over the age of 18
• Women scheduled for minimally invasive sacrocolpopexy with or without concomitant anti-incontinence procedure and with or without concomitant hysterectomy
• American Society of Anesthesiologists (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 (NPS) of more than 4 at baseline
• Renal/Liver disease
• Diabetes mellitus
• Pregnancy
• Inability to answer questionnaires
• Any systemic infections
• Immuno compromised status

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33326, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Dexamethasone; Steroids; Saline Solution

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• David Ossin, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 29, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)