Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial)

ISRCTN	ISRCTN21973627
DOI	https://doi.org/10.1186/ISRCTN21973627
Clinical Trials Information System (CTIS)	2010-022894-32
Protocol serial number	10426
Sponsor	University of Birmingham (UK)
Funders	Bowel Disease Research Foundation, Research for Patient Benefit (RfPB) (UK)

Submission date: 26/06/2012
Registration date: 26/06/2012
Last edited: 20/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Laura Magill
Scientific

University of Birmingham
School of Health & Population Sciences
College of Medical and Dental Sciences
Public Health Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 4159105
Email	e.l.magill@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Prevention
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - a prospective, double-blind, multicentre, randomised control trial
Study acronym	DREAMS
Study objectives	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.
Ethics approval(s)	10/H0402/77; First MREC approval date 16/02/2011
Health condition(s) or problem(s) studied	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
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 measure(s)	Number of episodes of vomiting recorded prospectively 24 hours post-op
Key secondary outcome measure(s)	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
Completion date	23/07/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1350
Key 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
Key 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
Date of first enrolment	20/06/2011
Date of final enrolment	31/01/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

University of Birmingham

Birmingham
B15 2TH
United Kingdom

49 sites in the UK

-
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/04/2017		Yes	No
Protocol article	protocol	12/08/2013		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/04/2017: Publication reference added.

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.