Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Laura Magill


Contact details

University of Birmingham
School of Health & Population Sciences
College of Medical and Dental Sciences
Public Health Building
B15 2TT
United Kingdom
+44 (0)121 4159105

Additional identifiers

EudraCT number

2010-022894-32 number

Protocol/serial number


Study information

Scientific title

Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - a prospective, double-blind, multicentre, randomised control trial



Study hypothesis

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

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.

Ethics approval

10/H0402/77; First MREC approval date 16/02/2011

Study design

Randomised; Interventional; Design type: Prevention

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


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


Patients are randomized between 8 mg intravenous dexamethasone and control (no dexamethasone)

Follow Up Length: 1 month(s)

Intervention type



Phase IV

Drug names

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

Overall trial start date


Overall trial end date


Reason abandoned


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 type


Age group




Target number of participants

Planned sample size: 950; total number of patients recruited: 1350

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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
B15 2TH
United Kingdom

Trial participating centre

49 sites in the UK
United Kingdom

Sponsor information


University of Birmingham (UK)

Sponsor details

B15 2TT
United Kingdom

Sponsor type




Funder type


Funder name

Bowel Disease Research Foundation

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Funder name

Research for Patient Benefit (RfPB) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

1. Collaborators across the UK will have the results presented to them
2. Patients will be sent a summary of the results in letter form
3. The main publication of results will be submitted to a major journal
4. The results will be sent to NICE
5. The publication of the results will be available on the University of Birmingham Website

Intention to publish date


Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in:

Publication citations

  1. Protocol

    Hamilton E, Ravikumar R, Bartlett D, Hepburn E, Hwang MJ, Mirza N, Bahia SS, Wilkey A, Bodenham Chilton H, Handley K, Magill L, Morton D, , Dexamethasone reduces emesis after major gastrointestinal surgery (DREAMS)., Trials, 2013, 14, 249, doi: 10.1186/1745-6215-14-249.

Additional files

Editorial Notes