Postoperative Nausea and Vomiting | Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting
Postoperative Nausea and Vomiting research study
What is the primary objective of this study?
Postoperative nausea and vomiting (PONV) are frequent after surgery and anaesthesia. Dexamethasone is widely used as antiemetic for the prevention of PONV. Little is known about the efficacy of antiemetic drugs for the treatment of established PONV symptoms. No single randomised trial has been published so far that tests the efficacy of dexamethasone for the treatment of established PONV symptoms. In this trial the investigators want to test the antiemetic efficacy of three different doses of intravenous dexamethasone for the treatment of established PONV symptoms. In adjunct protocols of this study the investigators aim to establish a novel method to quantify the anti-nausea efficacy of an antiemetic drug, to study pharmacogenetics of PONV, and to further our understanding on the smoking status as a predictive factor of PONV.
Who is eligible to participate?
Inclusion Criteria: - Adults (age ≥18 years), male or female. - American Society of Anesthesiology (ASA) status I to III. - Able to read and understand the information sheet - Subjects who have signed and dated the consent form. - Scheduled for elective surgery. - If the patient is female and of childbearing potential, she must have a negative pregnancy test (serum hCG or urine dipstick). Exclusion criteria: - A history of allergy or hypersensitivity to dexamethasone or any component of its formulation. - Hepatic dysfunction* (i.e bilirubin <1.5 upper limit normal (ULN), alanine aminotransferase (ALT) <2.5 x ULN, aspartate aminotransferase (AST) <2.5 x ULN). - Renal insufficiency* (i.e. creatinine <1.5 x ULN, creatinine clearance <30ml min-1). - Pregnant, or intending to become pregnant, women. - Breastfeeding women. - Patient having used any investigational drug within 30 days of screening. - Patient having participated in any clinical trial within 30 days. - Patients with active GI ulcer. - Patients needing prolonged postoperative intubation. - Patients needing a gastric tube postoperatively. - Patients receiving antiemetic drugs (butyrophenones, 5-HT3 receptor antagonists, dexamethasone). - Patients taking drugs that interfere with platelet aggregation (for instance, aspirine or clopidogrel) within seven days preoperatively. - Patients with overt psychosis or taking antipsychotic treatment (for instance, anti-dopaminergic drugs). - Patients taking drugs with known emetogenic potency (for instance, L-Dopa, COMT inhibitors). - Specific types of surgery: tonsillectomy (increased risk of postoperative bleeding), interventions that require strict prevention of postoperative vomiting. - Systemic infections (bacterial, fungal, malaria, viral, tuberculosis). - Local infections (for instance, ocular herpes simplex).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Postoperative Nausea and Vomiting
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PlaceboInjection of placebo (saline 0.9%)
Drug:Dexamethasone 3 mg10 ml Seringue with Dexamethasone
Drug:Dexamethasone 6 mg10 ml Seringue with Dexamethasone
Drug:Dexamethasone 12 mg10 ml Seringue with Dexamethasone
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Injection of PlaceboIntravenous Saline 0.9% 10 ml
Dexamethasone 3 mgIntravenous Dexamethasone 3mg diluted in saline 0.9% up to 10 ml
Dexamethasone 6 mgIntravenous Dexamethasone 6mg diluted in saline 0.9% up to 10 ml
Dexamethasone 12 mgIntravenous Dexamethasone 12mg diluted in saline 0.9% up to 10 ml
Start Date: August 2012
Completed Date: August 2018
Phase: Phase 2
Primary Outcome: Treatment efficacy of Dexamethasone for established PONV
Secondary Outcome: Short term efficacity
Study sponsors, principal investigator, and references
Principal Investigator: Martin R Tramèr, Prof.
Lead Sponsor: University Hospital, Geneva
Collaborator: Swiss National Science Foundation