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Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Total intravenous anesthesia

Total intravenous anesthesia plus palonosetron

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Palonosetron, PONV(postoperative nausea and vomiting), TIVA(Total intravenous anesthesia)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

ASA Physical Status 1 or 2
Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
Vomiting or retching in the 24 h preceding surgery
Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
Ongoing vomiting from gastrointestinal disease

Sites / Locations

Incheon St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Tiva group (Group T)

TIVA plus palonosetron group (Group T+P)

Arm Description

Outcomes

Primary Outcome Measures

Incidence of postoperative nausea and vomiting

Secondary Outcome Measures

Severity of nausea

Full Information

NCT ID

NCT01478165

First Posted

November 21, 2011

Last Updated

November 22, 2011

Sponsor

Incheon St.Mary's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01478165

Brief Title

Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting

Official Title

Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Incheon St.Mary's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the incidence of postoperative nausea and vomiting (PONV). Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is added to TIVA.

6. Conditions and Keywords

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

Postoperative Nausea and Vomiting

Keywords

Palonosetron, PONV(postoperative nausea and vomiting), TIVA(Total intravenous anesthesia)

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tiva group (Group T)

Arm Type

Placebo Comparator

Arm Title

TIVA plus palonosetron group (Group T+P)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Total intravenous anesthesia

Intervention Description

Total intravenous anesthesia plus normal saline 1.5 ml immediately before induction of anesthesia

Intervention Type

Drug

Intervention Name(s)

Total intravenous anesthesia plus palonosetron

Intervention Description

Total intravenous anesthesia plus palonosetron 0.075 mg(1.5 ml)immediately before induction of anesthesia

Primary Outcome Measure Information:

Title

Incidence of postoperative nausea and vomiting

Time Frame

For 24 hours after surgery

Secondary Outcome Measure Information:

Title

Severity of nausea

Time Frame

For 24 hours after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA Physical Status 1 or 2 Elective gynaecological laparoscopic surgery of ≥ 1h duration Exclusion Criteria: Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation Vomiting or retching in the 24 h preceding surgery Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry Ongoing vomiting from gastrointestinal disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soo Kyoung Park

Organizational Affiliation

Incheon St.Mary's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Incheon St. Mary's hospital

City

Incheon

ZIP/Postal Code

403-720

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting

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