Quality of RecoveryPhase 2NCT03338400
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
A Phase 2 study testing Dexamethasone and Normal saline in people with Quality of Recovery and Same Day Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative
- What is being tested?
- Dexamethasone and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 21 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Diabetes mellitus
- Pregnancy
- Inability to answer questionnaires
- Any systemic infections
- Immuno compromised status
- Patients with planned overnight stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
Read the 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.
- Conditions
- Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative, Vaginal Prolapse
- Being tested
- Dexamethasone, Normal saline
- Keywords
- Quality of Recovery, Dexamethasone, Same day surgery
- Medical subject headings
- Postoperative Nausea and Vomiting, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.
Normal salineDrug
Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Patients in the Dexamethasone arm will be administered the drug at the time of induction. Receives: Drug: Dexamethasone |
| Normal Saline | Placebo comparator | The placebo arm patients will receive normal saline at the time of induction. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
Nausea, Vomiting
Clinically important nausea >50
Measured: 24 hrs
Urinary Tract Infections
Number of UTIs diagnosed in each group
Measured: until 6 weeks
Readmissions
Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.
Measured: 6 weeks
Pain Level
numerical pain scale ranges from 0 to 10, where lower scores represent less pain.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 May 2017
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Hurtado, The Cleveland Clinic
- Investigators
- G. Willy Davila, Principal investigator, Department Head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338400
- Sponsor's protocol ID
- FLA17028
- Status last verified
- Mar 2021
- First submitted
- 20 Oct 2017
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Reconstructive Surgery: Is There A Role?
- ClinicalTrials.gov ID
- NCT03338400
- Acronym / sponsor ID
- FLA17028
- Conditions
- Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative, Vaginal Prolapse
- Keywords
- Quality of Recovery, Dexamethasone, Same day surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasonePatients in the Dexamethasone arm will be administered the drug at the time of induction. |
| Normal Saline | Placebo comparator | Drug: Normal salineThe placebo arm patients will receive normal saline at the time of induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasonePatients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction. | Drug | Dexamethasone |
| Normal salinePatients randomized to normal saline will receive 2ml of Normal saline at the time of induction. | Drug | Normal Saline |
Primary outcome
Questionnaire: Quality of Recovery 40
Time frame: 24 hours
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.
4 secondary outcomes
Nausea, Vomiting
Time frame: 24 hrs
Urinary Tract Infections
Time frame: until 6 weeks
Readmissions
Time frame: 6 weeks
Pain Level
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Willy Davila principal investigator
Department Head
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone and Normal saline in people with Quality of Recovery and Same Day Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire: Quality of Recovery 40 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.