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CompletedNCT01478165Updated Nov 23, 2011

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

An interventional study of Total intravenous anesthesia and Total intravenous anesthesia plus palonosetron in Postoperative Nausea and Vomiting, sponsored by Incheon St.Mary's Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2011-11-23.

Sponsored by Incheon St.Mary's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
19 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Postoperative Nausea and Vomiting

Keywords

  • Palonosetron
  • PONV(postoperative nausea and vomiting)
  • TIVA(Total intravenous anesthesia)
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 100 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Incheon St.Mary's Hospital is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    Tiva group (Group T)

    Drug: Total intravenous anesthesia

  • Active comparator
    TIVA plus palonosetron group (Group T+P)

    Drug: Total intravenous anesthesia plus palonosetron

Interventions

  • DrugTotal intravenous anesthesia

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

  • DrugTotal intravenous anesthesia plus palonosetron

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

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: For 24 hours after surgery

Secondary outcomes

  1. Severity of nausea

    Time frame: For 24 hours after surgery

07

Study locations

1 site
  • Incheon St. Mary's hospital
    Incheon, 403-720, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01478165
Lead sponsor
Incheon St.Mary's Hospital
Responsible party
Soo Kyoung Park (Clnical professor, Incheon St.Mary's Hospital) — Principal investigator
First posted
Nov 23, 2011
Start date
Sep 2011
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Nov 23, 2011

Study contacts

Soo Kyoung Park
principal investigator · Incheon St.Mary's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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