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

Overview

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.

Full Title of Study: “Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2011

Interventions

  • Drug: Total intravenous anesthesia
    • Total intravenous anesthesia plus normal saline 1.5 ml immediately before induction of anesthesia
  • Drug: Total intravenous anesthesia plus palonosetron
    • Total intravenous anesthesia plus palonosetron 0.075 mg(1.5 ml)immediately before induction of anesthesia

Arms, Groups and Cohorts

  • Placebo Comparator: Tiva group (Group T)
  • Active Comparator: TIVA plus palonosetron group (Group T+P)

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of postoperative nausea and vomiting
    • Time Frame: For 24 hours after surgery

Secondary Measures

  • Severity of nausea
    • Time Frame: For 24 hours after surgery

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Incheon St.Mary’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soo Kyoung Park, Clnical professor – Incheon St.Mary’s Hospital
  • Overall Official(s)
    • Soo Kyoung Park, Principal Investigator, Incheon St.Mary’s Hospital

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