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Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

NCT ID: NCT01543945

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Keywords

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Postoperative Nausea and Vomiting Ambulatory Gynecologic laparoscopy Incidence of postoperative nausea and vomiting.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Multimodal antiemetic management group

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

4 mg iv before induction for high and extremely high risk

Ondansetron

Intervention Type DRUG

4 mg iv before ended surgery 30 min

Dimenhydrinate

Intervention Type DRUG

1 mg/kg iv before ended surgery 30 min

Control group

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

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

4 mg iv before ended surgery 30 min

Interventions

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Dexamethasone

4 mg iv before induction for high and extremely high risk

Intervention Type DRUG

Ondansetron

4 mg iv before ended surgery 30 min

Intervention Type DRUG

Dimenhydrinate

1 mg/kg iv before ended surgery 30 min

Intervention Type DRUG

Other Intervention Names

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Multimodal antiemetic group : high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Thanyamon Asampinwat

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thanyamon Asampinwat, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Anesthesiology Department, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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PONV9268

Identifier Type: -

Identifier Source: org_study_id