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

NCT ID: NCT01478165

Last Updated: 2011-11-23

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tiva group (Group T)

Group Type PLACEBO_COMPARATOR

Total intravenous anesthesia

Intervention Type DRUG

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

TIVA plus palonosetron group (Group T+P)

Group Type ACTIVE_COMPARATOR

Total intravenous anesthesia plus palonosetron

Intervention Type DRUG

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

Interventions

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Total intravenous anesthesia

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

Intervention Type DRUG

Total intravenous anesthesia plus palonosetron

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Incheon St.Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Kyoung Park

Clnical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Kyoung Park

Role: PRINCIPAL_INVESTIGATOR

Incheon St.Mary's Hospital

Locations

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Incheon St. Mary's hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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OC11MISI0090

Identifier Type: -

Identifier Source: org_study_id