ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03338400
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Quality of Recovery Same Day Surgery Nausea and Vomiting, Postoperative Vaginal Prolapse Drug: Dexamethasone Drug: Normal saline Phase 2

Detailed Description:

The lifetime risk of undergoing surgical intervention for pelvic organ prolapse (POP) is estimated to be 10% and it is projected that from 2010 to 2050, the number of surgeries for POP will rise by 47.2%, from 166,000 to 245,970. In 1980, accounting for the rising costs of health care, congress approved Medicare to reimburse procedures performed at outpatient and ambulatory surgery centers. This led to an increasing number of stress incontinence (SUI) procedures being performed in the ambulatory setting from 34,968 in 1996 to 105,656 in 2006. However, the number of ambulatory POP surgeries decreased in the same time period. This was possibly due to the increase in the mean age of women undergoing ambulatory procedures for POP and SUI during that time periods.

At the investigator's institution has performed outpatient surgeries for POP and SUI for the past 3 years. Patients have tolerated same day surgery with minimal complications. In the investigator's previous prospective study assessing satisfaction after outpatient surgeries for POP and SUI, patients had a decreased quality of recovery at 48 hours compared to baseline. The investigators also recognized that nausea and pain control could have been better addressed. Unpleasant postoperative nausea and vomiting, pain control, return to normal voiding and return of bowel function can influence the quality of recovery (QOR) from surgery.

Postoperative nausea and vomiting (PONV) and pain management are particularly troubling for the patients. This might also delay discharge and prolong convalescence from the surgery.

Several safe interventions have been assessed in the literature for alleviating PONV, pain and recovery from laparoscopic gynecologic surgery.

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 hamper the production and release of anti-inflammatory mediators, thereby decreasing postoperative nausea, emesis, pain perception and 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.

Pauls et al in their recent study randomized patients undergoing vaginal prolapse surgery to receive Dexamethasone and noted a decrease in PONV and reduced requirement of a rescue antiemetic. Their model involved patients with overnight stay and the results may not be applicable to our population. They also noted that women who received Dexamethasone preoperatively were more likely to pass the voiding trial.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexamethasone
Patients in the Dexamethasone arm will be administered the drug at the time of induction.
Drug: Dexamethasone
Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.

Placebo Comparator: Normal Saline
The placebo arm patients will receive normal saline at the time of induction.
Drug: Normal saline
Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.




Primary Outcome Measures :
  1. Questionnaire: Quality of Recovery 40 [ Time Frame: 24 hours, 6 weeks ]
    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 QoR. This would be measured using the Quality of Recovery 40 questionnaire.


Secondary Outcome Measures :
  1. Nausea, Vomiting [ Time Frame: 24 hrs ]
    Patients will be administered a postoperative nausea, vomiting scale. The "Post Operative Nausea Scale" ranges from 0 to 77, where lower scores are improved outcomes.

  2. Urinary tract infections [ Time Frame: until 6 weeks ]
  3. readmissions [ Time Frame: 6 weeks ]
    Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.

  4. Pain level [ Time Frame: 24 hours ]
    numerical pain scale ranges from 0 to 10, where lower scores represent less pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The surgeries that are performed are only vaginal prolapse surgeries in a female pelvic medicine and reconstructive surgery department.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338400


Contacts
Contact: Jeffrey Schachar, MD 9546595559 schachj@ccf.org
Contact: Bridget Howard 216-445-5116 irb@ccf.org

Locations
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Jeffrey Schachar, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: G. Willy Davila Department Head

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03338400     History of Changes
Other Study ID Numbers: FLA17028
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The Cleveland Clinic:
Quality of Recovery, Dexamethasone, Same day surgery

Additional relevant MeSH terms:
Vomiting
Prolapse
Uterine Prolapse
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse
Postoperative Complications
Pathologic Processes
Nausea
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action