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Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Dexamethasone

Ondansetron

Dimenhydrinate

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Ambulatory, Gynecologic laparoscopy, Incidence of postoperative nausea and vomiting.

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Anesthesiology Department, Faculty of Medicine, Prince of Songkla University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal antiemetic management group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of PONV in ambulatory gynecologic laparoscopy

Secondary Outcome Measures

Full Information

NCT ID

NCT01543945

First Posted

February 28, 2012

Last Updated

July 29, 2012

Sponsor

Prince of Songkla University

1. Study Identification

Unique Protocol Identification Number

NCT01543945

Brief Title

Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince of Songkla University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

340 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal antiemetic management group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

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

Intervention Description

4 mg iv before induction for high and extremely high risk

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

4 mg iv before ended surgery 30 min

Intervention Type

Drug

Intervention Name(s)

Dimenhydrinate

Intervention Description

1 mg/kg iv before ended surgery 30 min

Primary Outcome Measure Information:

Title

Incidence of PONV in ambulatory gynecologic laparoscopy

Time Frame

four year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thanyamon Asampinwat, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anesthesiology Department, Faculty of Medicine, Prince of Songkla University

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

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Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

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