A Phase 2 interventional study of Dexamethasone and Normal saline in Quality of Recovery, Same Day Surgery and Nausea and Vomiting, Postoperative, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-14.
Sponsored by The Cleveland Clinic · Phase 2, Interventional, and Treatment
Among 82 studies testing dexamethasone in Postoperative Nausea and Vomiting — 10 open to participants now, 11 under way, 2 of them phase 3. Dexamethasone · Postoperative Nausea and Vomiting.
Among the 82 studies testing dexamethasone in Postoperative Nausea and Vomiting, this one is the 78th largest by enrollment, is one of 6 that started in 2017, is one of 7 in phase 2, and was the 43rd registered.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's enrollment of 51 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →10 of the 82 studies testing dexamethasone in Postoperative Nausea and Vomiting are open now, in 7 countries. Each count lists the studies.
Dexamethasone: first FDA approval 1958 (DECADRON), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 65 Postoperative Nausea and Vomiting studies recruiting now, 22 (34%) set no upper age limit and 37 (57%) stop at 75 or younger; 14 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 12 · Phase 4 37
First in 2002; this study’s year is marked. 6 started in 2017.
Median enrollment 121 across the 82 interventional studies. Of the 59 that completed or were terminated, 16 (27%) have results posted.
None of the 82 has an industry lead sponsor. The 10 most frequent:
The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
The Cleveland Clinic has 4 studies filed under Postoperative Nausea and Vomiting — fewer than ten, so there is no comparison to draw.
4 of the studies testing dexamethasone in Postoperative Nausea and Vomiting that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06997419Beijing Tiantan HospitalDexamethasone Palmitate for PONV After Open Surgery | 2026-11-30 |
| NCT07099222University of ArizonaEfficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks | 2026-12-31 |
| NCT06988124Beijing Tiantan HospitalDexamethasone Palmitate for PONV After Craniotomy | 2027-05-01 |
| NCT07615595University Medical Center Ho Chi Minh City (UMC)Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery | 2027-07-31 |
Among the 82 studies testing dexamethasone in Postoperative Nausea and Vomiting, from their registry updates:
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the Dexamethasone arm will be administered the drug at the time of induction.
Drug: Dexamethasone
The placebo arm patients will receive normal saline at the time of induction.
Drug: Normal saline
Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.
Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
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.
Time frame: 24 hours
Nausea, Vomiting
Clinically important nausea \>50
Time frame: 24 hrs
Urinary Tract Infections
Number of UTIs diagnosed in each group
Time frame: until 6 weeks
Readmissions
Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.
Time frame: 6 weeks
Pain Level
numerical pain scale ranges from 0 to 10, where lower scores represent less pain.
Time frame: 24 hours
| Milestone | Dexamethasone | Normal Saline |
|---|---|---|
| Started | 25 | 26 |
| Completed | 24 | 24 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
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.
| score on a scale | Dexamethasone | Normal Saline |
|---|---|---|
| Questionnaire: Quality of Recovery 40 | 174 ± 14.49 | 167 ± 16.02 |
Clinically important nausea \>50
| participants | Normal Saline | Dexamethasone |
|---|---|---|
| Nausea, Vomiting | 2 | 2 |
Number of UTIs diagnosed in each group
| participants | Normal Saline | Dexamethasone |
|---|---|---|
| Urinary Tract Infections | 1 | 2 |
Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.
| participants | Normal Saline | Dexamethasone |
|---|---|---|
| Readmissions | 4 | 1 |
numerical pain scale ranges from 0 to 10, where lower scores represent less pain.
| score on a scale | Normal Saline | Dexamethasone |
|---|---|---|
| Pain Level | 6.04 ± 2.8 | 4.77 ± 2.59 |
Collected over Adverse event data was collected over 6 month period of time.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Normal Saline | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | Dexamethasone | Normal Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 8 | 19 |
| >=65 years | 13 | 16 | 29 |
| Age, Continuous(years) | Dexamethasone | Normal Saline | Total |
|---|---|---|---|
| Mean | 66 (40 to 83) | 65 (34 to 85) | 65 (34 to 85) |
| Sex: Female, Male(Participants) | Dexamethasone | Normal Saline | Total |
|---|---|---|---|
| Female | 24 | 24 | 48 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Dexamethasone | Normal Saline | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 20 | 22 | 42 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Dexamethasone | Normal Saline | Total |
|---|---|---|---|
| United States | 24 | 24 | 48 |
| Body Mass Index(kg/m2) | Dexamethasone | Normal Saline | Total |
|---|---|---|---|
| Mean | 26 (18 to 38) | 28 (21 to 39) | 27 (18 to 39) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2017 to primary completion in Aug 2018, 15 months.
Results were first posted in May 2019, 8 months after primary completion.
Of 17 phase 2 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 29. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Postoperative Nausea and Vomiting →