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NCT01482468 Clinical Trial

Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:
Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01482468
Other study ID # OC11MISI0109
Secondary ID
Status Recruiting
Phase N/A
First received November 28, 2011
Last updated March 21, 2012
Start date March 2012
Est. completion date July 2012

Study information
Verified date March 2012
Source Incheon St.Mary's Hospital
Contact Soo Kyoung Park
Phone 82-32-280-5410
Email hardmong@korea.com
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 132
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Female
Age group 20 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

Intervention

Drug:
• continuous infusion of palonosetron added to prophylactic single injection of palonosetron
continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg
• continuous infusion of normal saline added to prophylactic single injection of palonosetron
continuous infusion of normal saline after single injection of palonosetron 0.075mg

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 24 hours after surgery No
Secondary severity of nausea for 24 hours after sugery No
See also
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Recruiting NCT04069806 - Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section N/A
Completed NCT04043247 - Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting N/A
Terminated NCT01975727 - Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting Phase 2
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT00090155 - 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED) Phase 3
Recruiting NCT05375721 - Prevention of PONV With Traditional Chinese Medicine N/A
Completed NCT02480088 - Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism Phase 4
Recruiting NCT06137027 - Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting Early Phase 1
Not yet recruiting NCT05529004 - A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy Phase 2
Completed NCT02944942 - Risk Factors for Postoperative Nausea/Vomiting N/A
Recruiting NCT02571153 - Low Doses of Ketamine and Postoperative Quality of Recovery Phase 4
Completed NCT02449291 - Study of APD421 as PONV Treatment (no Prior Prophylaxis) Phase 3
Completed NCT02550795 - Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer N/A
Recruiting NCT01442012 - Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery N/A
Completed NCT01478165 - Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting N/A
Unknown status NCT01268748 - Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain N/A
Completed NCT02143531 - Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting Phase 4
Completed NCT00734929 - Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy Phase 4