NCT01543945

Brief Summary

The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

3.8 years

First QC Date

February 28, 2012

Last Update Submit

July 29, 2012

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and VomitingAmbulatoryGynecologic laparoscopyIncidence of postoperative nausea and vomiting.

Outcome Measures

Primary Outcomes (1)

  • Incidence of PONV in ambulatory gynecologic laparoscopy

    four year

Study Arms (2)

Multimodal antiemetic management group

EXPERIMENTAL

Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg

Drug: DexamethasoneDrug: OndansetronDrug: Dimenhydrinate

Control group

ACTIVE COMPARATOR

Control group: Low and moderate risk : no PONV prophylaxis High risk : Ondansetron 4 mg. iv Extremely high risk : Ondansetron 4 mg .iv

Drug: Ondansetron

Interventions

DexamethasoneDRUG

4 mg iv before induction for high and extremely high risk

Also known as: Multimodal antiemetic group :, high risk : dexamethasone 4 mg + ondansetron 4 mg, Extremely high risk : dexamethasone 4 mg +, ondansetron 4 mg +, dimenhydrinate 1 mg
Multimodal antiemetic management group
OndansetronDRUG

4 mg iv before ended surgery 30 min

Control groupMultimodal antiemetic management group
DimenhydrinateDRUG

1 mg/kg iv before ended surgery 30 min

Multimodal antiemetic management group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ambulatory gynecologic laparoscopy
  • Age 18-45 years
  • ASA class 1-2

You may not qualify if:

  • The patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery
  • History of antiemetic, anesthetic and analgesic drugs allergy
  • Pregnancy or breast feeding
  • Body mass index \>34 kg/square metre

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology Department, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingVomiting

Interventions

DexamethasoneOndansetronDimenhydrinate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingDiphenhydramineEthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTheophyllineXanthinesPurinonesPurinesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Thanyamon Asampinwat, MD

    Anesthesiology department, Faculty of Medicine, Prince of Songkla University Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

March 1, 2008

Primary Completion

December 1, 2011

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

TH(1)