Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting

NCT01975727 | Terminated Phase 2 DMC

• 1 other identifier: CER 11-213 (NAC 11-076)
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting; Vomiting

Keywords

PONV; Dexamethasone; Treatment

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy of Dexamethasone for established PONV

  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.

  24 hour follow up

Secondary Outcomes (4)

• Short term efficacity

  6 hours

• PONV free after rescue antiemtic

  24 hour follow up

• Quality of sleep

  24 hour follow up

• Minor or major adverse effects

  24 hour follow up

Study Arms (4)

Injection of Placebo

PLACEBO COMPARATOR

Intravenous Saline 0.9% 10 ml

Drug: Placebo

Dexamethasone 3 mg

ACTIVE COMPARATOR

Intravenous Dexamethasone 3mg diluted in saline 0.9% up to 10 ml

Drug: Dexamethasone 3 mg

Dexamethasone 6 mg

ACTIVE COMPARATOR

Intravenous Dexamethasone 6mg diluted in saline 0.9% up to 10 ml

Drug: Dexamethasone 6 mg

Dexamethasone 12 mg

ACTIVE COMPARATOR

Intravenous Dexamethasone 12mg diluted in saline 0.9% up to 10 ml

Drug: Dexamethasone 12 mg

Interventions

Placebo DRUG

Injection of placebo (saline 0.9%)

Also known as: Intravenous saline 0.9%

Injection of Placebo

Dexamethasone 3 mg DRUG

10 ml Seringue with Dexamethasone

Also known as: Corticosteroid

Dexamethasone 3 mg

Dexamethasone 6 mg DRUG

10 ml Seringue with Dexamethasone

Also known as: Corticosteroid

Dexamethasone 6 mg

Dexamethasone 12 mg DRUG

10 ml Seringue with Dexamethasone

Also known as: Corticosteroid

Dexamethasone 12 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Swiss National Science Foundation: collaborator

Study Sites (4)

University Hospital of Lausanne (CHUV), Division of Anaesthesiology,

Lausanne, Canton of Vaud, Switzerland

Location

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

Hôpital HNE-Pourtales

Neuchâtel, 2000, Switzerland

Location

Hôpital d'Yverdon-les-Bains

Yverdon-les-Bains, 1400, Switzerland

Location

Related Publications (1)

• Czarnetzki C, Albrecht E, Desmeules J, Kern C, Corpataux JB, Gander S, van Kuijk SMJ, Tramer MR. Dexamethasone for the treatment of established postoperative nausea and vomiting: A randomised dose finding trial. Eur J Anaesthesiol. 2022 Jun 1;39(6):549-557. doi: 10.1097/EJA.0000000000001636. Epub 2021 Nov 16.

  PMID: 34799501 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Interventions

Dexamethasone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Martin R Tramèr, Prof.

  University Hospitals of Geneva

  STUDY CHAIR

• Christoph Czarnetzki, MD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsable Investigator

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 5, 2013
• Study Start: September 3, 2012
• Primary Completion: November 8, 2017
• Study Completion: November 9, 2017
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)