Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

Incheon St.Mary's Hospital

Status: Unknown

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron; Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01482468

OC11MISI0109

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

continuous infusion

Active Comparator group

Description:

continuous infusion of palonosetron added to prophylactic single injection of palonosetron

Treatment:

Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron

singel injection

Placebo Comparator group

Description:

continuous infusion of normal saline added to prophylactic single injection of palonosetron

Treatment:

Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetron