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Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting (DexPonv)

This study is currently recruiting participants.
Verified June 2017 by Christoph Czarnetzki, University Hospital, Geneva
Sponsor:
ClinicalTrials.gov Identifier:
NCT01975727
First Posted: November 5, 2013
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christoph Czarnetzki, University Hospital, Geneva
  Purpose
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.

Condition Intervention Phase
Postoperative Nausea and Vomiting Vomiting Drug: Placebo Drug: Dexamethasone 3 mg Drug: Dexamethasone 6 mg Drug: Dexamethasone 12 mg Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting - a Randomised, Placebo-controlled, Dose-finding Study

Resource links provided by NLM:


Further study details as provided by Christoph Czarnetzki, University Hospital, Geneva:

Primary Outcome Measures:
  • Treatment efficacy of Dexamethasone for established PONV [ Time Frame: 24 hour follow up ]
    Complete absence of any nausea and/or vomiting (including retching) in a previously nauseated or vomiting patient within 24 hours after administration of the study treatment.


Secondary Outcome Measures:
  • Short term efficacity [ Time Frame: 6 hours ]
    Free from PONV during the first 6 hours

  • PONV free after rescue antiemtic [ Time Frame: 24 hour follow up ]
    Number of patients staying PONV free after rescue antiemetic during the first 24 postoperative hours

  • Quality of sleep [ Time Frame: 24 hour follow up ]
    quality of sleep during the first postoperative night (numerical rating scale ranging from 0 = no sleep at all to 10 = excellent sleep)

  • Minor or major adverse effects [ Time Frame: 24 hour follow up ]
    any minor or major adverse effects during 24h.


Estimated Enrollment: 560
Actual Study Start Date: August 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Injection of Placebo
Intravenous Saline 0.9% 10 ml
Drug: Placebo
Injection of placebo (saline 0.9%)
Other Name: Intravenous saline 0.9%
Active Comparator: Dexamethasone 3 mg
Intravenous Dexamethasone 3mg diluted in saline 0.9% up to 10 ml
Drug: Dexamethasone 3 mg
10 ml Seringue with Dexamethasone
Other Name: Corticosteroid
Active Comparator: Dexamethasone 6 mg
Intravenous Dexamethasone 6mg diluted in saline 0.9% up to 10 ml
Drug: Dexamethasone 6 mg
10 ml Seringue with Dexamethasone
Other Name: Corticosteroid
Active Comparator: Dexamethasone 12 mg
Intravenous Dexamethasone 12mg diluted in saline 0.9% up to 10 ml
Drug: Dexamethasone 12 mg
10 ml Seringue with Dexamethasone
Other Name: Corticosteroid

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975727


Contacts
Contact: Christoph A Czarnetzki, MD, MBA 0041223723311 christoph.czarnetzki@hcuge.ch
Contact: Martin R Tramèr, MD, PhD 0041223723311 martin.tramer@hcuge.ch

Locations
Switzerland
University Hospital of Lausanne (CHUV), Division of Anaesthesiology, Not yet recruiting
Lausanne, Vaud, Switzerland
Contact: Christian Kern, Prof    004121 314 11 11    christian.kern@chuv.ch   
Principal Investigator: Christian Kern, Prof         
University Hospitals of Geneva Recruiting
Geneva, Switzerland, 1211
Contact: Christoph Czarnetzki, MD    0041795532113    christoph.czarnetzki@hcuge.ch   
Contact: Martin R Tramèr, Prof.    0041735532145    martin.tramèr@hcuge.ch   
Principal Investigator: Christoph Czarnetzki, MD         
Hôpital HNE-Pourtales Recruiting
Neuchâtel, Switzerland, 2000
Contact: Jean-Baptiste CORPATAUX, MD    0041327133818    jean-baptiste.corpataux@h-ne.ch   
Hôpital d'Yverdon-les-Bains Recruiting
verdon-les-Bains, Switzerland, 1400
Contact: Sylvain Gander, MD    0041244245030    sylvain.gander@ehnv.ch   
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Investigators
Study Chair: Martin R Tramèr, Prof. University Hospitals of Geneva
Principal Investigator: Christoph Czarnetzki, MD University Hospitals of Geneva
  More Information

Responsible Party: Christoph Czarnetzki, Responsable Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01975727     History of Changes
Other Study ID Numbers: CER 11-213 (NAC 11-076)
First Submitted: October 22, 2013
First Posted: November 5, 2013
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christoph Czarnetzki, University Hospital, Geneva:
PONV
Dexamethasone
Treatment

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action