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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01478165
First received: November 21, 2011
Last updated: November 22, 2011
Last verified: November 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of nausea [ Time Frame: For 24 hours after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Soo Kyoung Park, Clnical professor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01478165     History of Changes
Other Study ID Numbers: OC11MISI0090
Study First Received: November 21, 2011
Last Updated: November 22, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014