NCT01876290

Brief Summary

The investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

May 29, 2013

Last Update Submit

October 28, 2016

Conditions

Postoperative Nausea and Vomiting

Keywords

AnesthesiologyComplicationsClosed-loop

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea or vomiting

    Severe nausea (\> to 4 on a 0-10 visual analogue scale) or vomiting

    24 hours

Secondary Outcomes (5)

  • incidence of nausea

    one day after anesthesia

  • incidence of vomiting

    one day after anesthesia

  • rescue treatment

    one day after anesthesia

  • pain

    one day after anesthesia

  • sedation

    one day after surgery

Study Arms (2)

Dexamethasone and Ondansetron

EXPERIMENTAL

Each patient will receive Dexamethasone and Ondansetron

Drug: Dexamethasone and Ondansetron

Placebo

PLACEBO COMPARATOR

Each patient will receive placebo instead of Dexamethasone and Ondansetron

Drug: Placebo

Interventions

Dexamethasone and OndansetronDRUG

Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting

Dexamethasone and Ondansetron
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18-75 years
  • Scheduled for bariatric surgery under total intra-venous closed-loop anesthesia
  • Apfel score equal or greater than 2
  • Consenting to participate in the study

You may not qualify if:

  • Pregnant, breast feeding women
  • Allergy
  • Contraindication to dexamethasone
  • Contraindication to ondansetron
  • Contraindication to propofol, remifentanil, morphine, ketoprofen
  • Limit to the use of bispectral index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de la Baie des Citrons

Nouméa, 98800, France

Location

Related Publications (3)

  • Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

    PMID: 21233500BACKGROUND

  • Song JW, Park EY, Lee JG, Park YS, Kang BC, Shim YH. The effect of combining dexamethasone with ondansetron for nausea and vomiting associated with fentanyl-based intravenous patient-controlled analgesia. Anaesthesia. 2011 Apr;66(4):263-7. doi: 10.1111/j.1365-2044.2011.06648.x.

    PMID: 21401538BACKGROUND

  • Bataille A, Letourneulx JF, Charmeau A, Lemedioni P, Leger P, Chazot T, Le Guen M, Diemunsch P, Fischler M, Liu N. Impact of a prophylactic combination of dexamethasone-ondansetron on postoperative nausea and vomiting in obese adult patients undergoing laparoscopic sleeve gastrectomy during closed-loop propofol-remifentanil anaesthesia: A randomised double-blind placebo-controlled study. Eur J Anaesthesiol. 2016 Dec;33(12):898-905. doi: 10.1097/EJA.0000000000000427.

    PMID: 26866433DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

DexamethasoneOndansetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Marc Fischler, MD

    Hôpital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 12, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2015

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(1)