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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478165
• Other study ID #: OC11MISI0090
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: November 22, 2011
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Incheon St.Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting		For 24 hours after surgery	No
Secondary	Severity of nausea		For 24 hours after surgery	No