Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) | Not Recruiting
Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial)
DREAMS
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Topic: National Cancer Research Network, Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes
  • Subtopic: Colorectal Cancer, Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics)
  • Disease: Colon, Gastrointestinal, Surgery
Dr Laura Magill
+44 (0)121 4159105
See all trial contact details
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN21973627
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • Postoperative nausea and vomiting (PONV) is one of the most common complications affecting patients after major surgery. Patients undergoing bowel surgery are at a relatively high risk of developing these symptoms. This is often multifactorial and such patients are often exposed to various causative agents. Following surgery, patients view nausea and vomiting as a very undesirable effect, often reported as even more unpleasant than pain. It can cause significant consequences and given that over 60,000 bowel operations are performed in the UK annually, PONV is important because of its implications. Although the final outcome of surgery is rarely affected, PONV can cause significant complications such as dehydration, delayed return to oral diet, physiological disturbances and thus prolonging hospital stay. Delayed recovery predisposes to serious and life threatening complications such as hospital acquired pneumonia and thromboembolic events (deep vein thrombosis and pulmonary embolism). The delay in resuming an oral diet affects nutrition and subsequent general well being, predisposing to tissue breakdown, wound infection, fatigue, and weakness. For these reasons, reducing the severity of PONV is particularly important. Dexamethasone is a steroid drug widely but not universally used in attempt to prevent PONV by anaesthetists, and single dose dexamethasone has been reported to reduce PONV and perioperative fatigue. Its precise mechanism of action is unknown but it has antiemetic properties and is known to improve appetite aiding early recovery. Small studies have shown a reduction in PONV amongst patients undergoing various types of surgery who are given dexamethasone. However no multicentre trial has been undertaken. Its potential benefits for patients undergoing bowel surgery need to be investigated. The findings would ensure its appropriate use in the future. More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10426 On 11/08/2015 the following changes were made to the trial record: 1. The original target number of participants (sample size) was 950, however due to the rapid recruitment rate, the power of the trial was increased from 80% to 90%, and the target was thus increased to 1320. The target was reached in January 2014 and the total number of patients recruited was 1350, 6 months ahead of the original end date of July 2014 for only 950 patients. 2. Research for Patient Benefit (RfPB) (UK) was added to the sources of funding. 3. The overall trial end date was changed from 20/06/2014 to 23/07/2015.
Phase
Phase IV
Study Design
Randomised; Interventional; Design type: Prevention
Study Type
Interventional
Intervention

Patients are randomized between 8 mg intravenous dexamethasone and control (no dexamethasone) Follow Up Length: 1 month(s)

Intervention Type
Procedure/Surgery
Primary Outcome Measures
  • Number of episodes of vomiting recorded prospectively 24 hours post-op
Secondary Outcome Measures
  • 1. Fatigue measured one month post-op
  • 2. Frequency of use of post-op anti-emetics measured one month post-op
  • 3. Length of hospital stay
  • 4. Subjective measure of PONV measured one month post-op
  • 5. Time to tolerating oral diet measured one month post-op
Publication(s)
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23938028
Result Reports
Sorry, this information is not available
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned sample size: 950; total number of patients recruited: 1350
Participant Inclusion Criteria
  • 1. All patients undergoing laparoscopic and open colorectal resections for malignant or benign pathology
  • 2. Male & Female; Upper Age Limit 90 years ; Lower Age Limit 18 years
Participant Exclusion Criteria
  • 1. Obstructed procedures
  • 2. Pregnant patients
  • 3. Known adverse reaction to dexamethasone
  • 4. Patients currently taking any form of steroid medication
  • 5. Diabetic/ hyperglycaemic patients
  • 6. Active gastric ulceration
  • 7. Wideangle glaucoma
  • 8. Patients under the age of 18
  • 9. Patients unable or unwilling to give informed consent
Trial Location(s)
Birmingham
B15 2TH
-
Trial Contact(s)
Primary Trial Contact
Dr Laura Magill
e.l.magill@bham.ac.uk
+44 (0)121 4159105
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - a prospective, double-blind, multicentre, randomised control trial
EudraCT Number
2010-022894-32
Funder(s)
  • Bowel Disease Research Foundation
  • Research for Patient Benefit (RfPB) (UK)
Other Study ID Numbers
10426
Sponsor(s)
University of Birmingham (UK)
Key Dates

Recruitment Start Date

20 Jun 2011

Recruitment End Date

31 Jan 2014

Trial Start Date

20 Jun 2011

Trial End Date

23 Jul 2015

Date Assigned

26 Jun 2012

Last Updated

13 Aug 2015