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

This study has been completed.
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital Identifier:
First received: November 21, 2011
Last updated: November 22, 2011
Last verified: November 2011

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.

Condition Intervention
Postoperative Nausea and Vomiting
Drug: Total intravenous anesthesia
Drug: Total intravenous anesthesia plus palonosetron

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)

Resource links provided by NLM:

Further study details as provided by Incheon St.Mary's Hospital:

Primary Outcome Measures:
  • Incidence of postoperative nausea and vomiting [ Time Frame: For 24 hours after surgery ]

Secondary Outcome Measures:
  • Severity of nausea [ Time Frame: For 24 hours after surgery ]

Enrollment: 100
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Tiva group (Group T) Drug: Total intravenous anesthesia
Total intravenous anesthesia plus normal saline 1.5 ml immediately before induction of anesthesia
Active Comparator: TIVA plus palonosetron group (Group T+P) Drug: Total intravenous anesthesia plus palonosetron
Total intravenous anesthesia plus palonosetron 0.075 mg(1.5 ml)immediately before induction of anesthesia


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01478165

Korea, Republic of
Incheon St. Mary's hospital
Incheon, Korea, Republic of, 403-720
Sponsors and Collaborators
Incheon St.Mary's Hospital
Principal Investigator: Soo Kyoung Park Incheon St.Mary's Hospital
  More Information

Responsible Party: Soo Kyoung Park, Clnical professor, Incheon St.Mary's Hospital Identifier: NCT01478165     History of Changes
Other Study ID Numbers: OC11MISI0090
Study First Received: November 21, 2011
Last Updated: November 22, 2011

Keywords provided by Incheon St.Mary's Hospital:
PONV(postoperative nausea and vomiting)
TIVA(Total intravenous anesthesia)

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017