TY - JOUR
T1 - Dexamethasone reduces emesis after major gastrointestinal surgery (DREAMS)
AU - Hamilton, Emma
AU - Ravikumar, Reena
AU - Bartlett, David
AU - Hepburn, Elizabeth
AU - Hwang, Mei-Ju
AU - Mirza, Nazzia
AU - Bahia, Sandeep S
AU - Wilkey, Anthony
AU - Bodenham Chilton, Helen
AU - Handley, Kelly
AU - Magill, Laura
AU - Morton, Dion
AU - West Midlands Research Collaborative
PY - 2013/8/12
Y1 - 2013/8/12
N2 - BACKGROUND: Postoperative nausea and vomiting is one of the most common complications affecting patients after surgery and causes significant morbidity and increased length of hospital stay. It is accepted that patients undergoing surgery on the bowel are at a higher risk. In the current era of minimally invasive colorectal surgery combined with enhanced recovery, reducing the incidence and severity of postoperative nausea and vomiting is particularly important. Dexamethasone is widely, but not universally used. It is known to improve appetite and gastric emptying, thus reduce vomiting. However, this benefit is not established in patients undergoing bowel surgery, and dexamethasone has possible side effects such as increased risk of wound infection and anastomotic leak that could adversely affect recovery.DESIGN: 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.Patients undergoing laparoscopic or open colorectal resections for malignant or benign pathology are randomized between 8 mg intravenous dexamethasone and control (no dexamethasone). All patients are given one additional antiemetic at the time of induction, prior to randomization. Both the patient and their surgeon are blinded as to the treatment arm.Secondary objectives of the DREAMS trial are to determine whether there are other measurable benefits during recovery from surgery with the use of dexamethasone, including quicker return to oral diet and reduced length of stay. Health-related quality of life, fatigue and risks of infections will be investigated.TRIAL REGISTRATION: ISRCTN21973627.
AB - BACKGROUND: Postoperative nausea and vomiting is one of the most common complications affecting patients after surgery and causes significant morbidity and increased length of hospital stay. It is accepted that patients undergoing surgery on the bowel are at a higher risk. In the current era of minimally invasive colorectal surgery combined with enhanced recovery, reducing the incidence and severity of postoperative nausea and vomiting is particularly important. Dexamethasone is widely, but not universally used. It is known to improve appetite and gastric emptying, thus reduce vomiting. However, this benefit is not established in patients undergoing bowel surgery, and dexamethasone has possible side effects such as increased risk of wound infection and anastomotic leak that could adversely affect recovery.DESIGN: 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.Patients undergoing laparoscopic or open colorectal resections for malignant or benign pathology are randomized between 8 mg intravenous dexamethasone and control (no dexamethasone). All patients are given one additional antiemetic at the time of induction, prior to randomization. Both the patient and their surgeon are blinded as to the treatment arm.Secondary objectives of the DREAMS trial are to determine whether there are other measurable benefits during recovery from surgery with the use of dexamethasone, including quicker return to oral diet and reduced length of stay. Health-related quality of life, fatigue and risks of infections will be investigated.TRIAL REGISTRATION: ISRCTN21973627.
KW - Administration, Intravenous
KW - Antiemetics
KW - Clinical Protocols
KW - Dexamethasone
KW - Digestive System Surgical Procedures
KW - Double-Blind Method
KW - England
KW - Humans
KW - Length of Stay
KW - Postoperative Nausea and Vomiting
KW - Recovery of Function
KW - Research Design
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1186/1745-6215-14-249
DO - 10.1186/1745-6215-14-249
M3 - Article
C2 - 23938028
SN - 1745-6215
VL - 14
SP - 249
JO - Trials
JF - Trials
ER -