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

November 21, 2011
November 22, 2011
September 2011
November 2011   (final data collection date for primary outcome measure)
Incidence of postoperative nausea and vomiting [ Time Frame: For 24 hours after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01478165 on ClinicalTrials.gov Archive Site
Severity of nausea [ Time Frame: For 24 hours after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting
Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
  • 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
  • Placebo Comparator: Tiva group (Group T)
    Intervention: Drug: Total intravenous anesthesia
  • Active Comparator: TIVA plus palonosetron group (Group T+P)
    Intervention: Drug: Total intravenous anesthesia plus palonosetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01478165
OC11MISI0090
Yes
Soo Kyoung Park, Incheon St.Mary's Hospital
Incheon St.Mary's Hospital
Not Provided
Principal Investigator: Soo Kyoung Park Incheon St.Mary's Hospital
Incheon St.Mary's Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP