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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01478165
First Posted: November 23, 2011
Last Update Posted: November 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital
  Purpose

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: Quadruple (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 Soo Kyoung Park, 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

  Eligibility

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478165


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

Responsible Party: Soo Kyoung Park, Clnical professor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01478165     History of Changes
Other Study ID Numbers: OC11MISI0090
First Submitted: November 21, 2011
First Posted: November 23, 2011
Last Update Posted: November 23, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Palonosetron
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action