DREAMS: Does dexamethsone reduce emesis after major gastrointestinal surgery?

Trial Overview

Acronym	DREAMS
Number	ISRCTN21973627
Protocol Link	http://www.isrctn.com/ISRCTN21973627
Public Trial Registry Link	https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022894-32/GB
Published Results Link	https://www.ncbi.nlm.nih.gov/pubmed/?term=Dexamethasone+versus+standard+treatment+for+postoperative+nausea+and+vomiting+in+gastrointestinal+surgery%3A+randomised+controlled+trial+(DREAMS+Trial)
Status	Published
Category	Proctology
Treatment Course	Surgery

Trial Description

DREAMS is a phase III, double-blind, multicenter, randomized controlled trial with the primary objective of determining if preoperative dexamethasone reduces postoperative nausea and vomiting in patients undergoing elective gastrointestinal resections. DREAMS aims to randomize 1,350 patients over 2.5 years.

Chief Investigator

Dion Morton
Professor

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Lead Centre

The University Hospitals Birmingham NHS Foundation Trust
New Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston
Birmingham
B15 2GW
UK

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Collaboration and Funding

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Additional Information

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Objective:	The DREAMS trial is a 2 stage study: i) a feasibility study and ii) a phase IV randomsied controlled trial. The objective of the feasibility study is to assess the feasibility of running the phase IV study. This pilot trial will develope effective strategies for patient identification, recruitment and follow-up in the main part of the trial. The objective of the full trial is to determine whether dexamethasone reduces postoperative nausea and vomiting in patients undergoing planned major bowel surgery and to determine it's role in future use in this category of patients.
Aim:	The secondary objective of the phase IV trial is to determine whether there is a measurable benefit during recovery with the use of single dose dexamethasone. Benefits investigated will include quicker return to oral diet and reduced length of stay. The following secondary outcomes will be measured post-operatively. 1. Nausea and vomiting will be measured objectively by recording the frequency of use of post-operative anti-emetics. 2. Nausea will also be measured subjectively by the use of validated visual analogue scale (VAS). 3. Fatigue will be measured using a validated assessment score (FACT – Fatigue questionnaire). 4. Time to tolerate oral diet will be recorded. 5. Length of hospital stay. 6. Health-related quality of life (Euroqol EQ-5D) will be measured using a standardised questionaire. 7. Incremental cost-effectiveness of dexamethasone compared to standard care will also be measured. 8. As we will be using a steroid, we will evaluate patients for increased risks
Methods:	Patients undergoing laparoscopic or open gastrointestinal resections will be randomized, in a 1:1 ratio, between 8 mg intravenous dexamethasone and control. All patients must be given one additional antiemetic prior to randomization; however, this must not be dexamethasone.
Reason for International Trial:	.

Trial Details

DREAMS: Does dexamethsone reduce emesis after major gastrointestinal surgery?

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

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Trial Details

DREAMS: Does dexamethsone reduce emesis after major gastrointestinal surgery?

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

Why join us?

Members

Research

Education

News & Events

About ESCP

Contact Us

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