Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting
This study has been completed.
Sponsor:
Incheon St.Mary's Hospital
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
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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
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 May 22, 2013