Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - A prospective, double-blind, multicentre, randomised control trial | Not Recruiting
Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - A prospective, double-blind, multicentre, randomised control trial
DREAMS
Trial Source

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
Not Recruiting
Recruitment Status
ISRCTN21973627
Primary Trial ID Number
Summary
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 foudn at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10426
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
Research Question
  • 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 foudn at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10426
Design Type
Sorry, this information is not available
Ethics Approval
10/H0402/77; First MREC approval date 16/02/2011
Publications
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23938028
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
950
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
Interventions
Administration of IMP, 8mg IV dexamethasone Follow Up Length: 1 month(s)
Design Details
Sorry, this information is not available
Study Design
Randomised; Interventional; Design type: Prevention
Results Reporting
Sorry, this information is not available
Acronym
DREAMS
Scientific Title
Sorry, this information is not available
Secondary Trial Identifying Number
10426
Website
Sorry, this information is not available
Study Funded By
Bowel Disease Research Foundation (BDRF) (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Birmingham (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

20 Jun 2011

Recruitment End Date

20 Jun 2014

Trial End Date

20 Jun 2014

Date added to Registry

26 Jun 2012

Last Updated

15 Aug 2013