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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Geneva
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christoph Czarnetzki, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01975727
First received: October 22, 2013
Last updated: November 4, 2013
Last verified: October 2013
  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: Injection of Placebo (saline 0.9%)
Drug: Dexamethasone 3 mg intravenously
Drug: Dexamethasone 6 mg
Drug: Dexamethasone 12 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University Hospital, Geneva:

Primary Outcome Measures:
  • Treatment efficacy of Dexamethasone for established PONV [ Time Frame: 24 hour follow up ] [ Designated as safety issue: No ]
    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:
  • Evaluation of the potential adverse effect profile of dexamethasone [ Time Frame: 24 hour follow up ] [ Designated as safety issue: Yes ]
    Time to treatment failure

  • Evaluation of the potential adverse effect profile of dexamethasone [ Time Frame: 24 hour follow up ] [ Designated as safety issue: Yes ]
    blood glucose (in the morning after administration of study drug)

  • Evaluation of the potential adverse effect profile of dexamethasone [ Time Frame: 24 hour follow up ] [ Designated as safety issue: Yes ]
    quality of sleep during the first postoperative night (numerical rating scale ranging from 0 = no sleep at all to 10 = excellent sleep)

  • Evaluation of the potential adverse effect profile of dexamethasone [ Time Frame: 24 hour follow up ] [ Designated as safety issue: Yes ]
    any minor or major adverse effects during 24h.


Estimated Enrollment: 560
Study Start Date: August 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Injection of Placebo Drug: Injection of Placebo (saline 0.9%)
If the patient becomes nauseous and/or is vomiting postoperatively he/she will be randomised to receive the study treatment. In this arm he/she will receive an injection of saline 0.9% (placebo).
Active Comparator: Dexamethasone 3 mg Drug: Dexamethasone 3 mg intravenously
If the patient becomes nauseous and/or is vomiting postoperatively he/she will be randomised to receive the study treatment. In this arm he/she will receive an injection of 3 mg Dexamethasone.
Active Comparator: Dexamethasone 6 mg Drug: Dexamethasone 6 mg
If the patient becomes nauseous and/or is vomiting postoperatively he/she will be randomised to receive the study treatment. In this arm he/she will receive an injection of 6 mg Dexamethasone.
Active Comparator: Dexamethasone 12 mg Drug: Dexamethasone 12 mg
If the patient becomes nauseous and/or is vomiting postoperatively he/she will be randomised to receive the study treatment. In this arm he/she will receive an injection of 12 mg Dexamethasone.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults
  • ASA status I to III
  • Scheduled for elective surgery

Exclusion criteria:

  • Patients with diabetes or active GI ulcer
  • Undergoing tonsillectomy
  • Outpatient surgery or interventions that require strict prevention of postoperative vomiting
  • With planned prolonged postoperative intubation or gastric tube postoperatively
  • Receiving antiemetic drugs
  • Taking drugs with known emetogenic potency
  • With overt psychosis or taking antipsychotic treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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         
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

No publications provided

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)
Study First Received: October 22, 2013
Last Updated: November 4, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by 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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014