NCT01781377

Prophylactic Subhypnotic Propofol for Nausea and Vomiting During for Cesarean Section Under Subarachnoid Anesthesia.

Randomized Controlled Trial of Prophylactic Subhypnotic Propofol vs Metoclopramide and in Combination Therapy for the Prevention of Nausea and Vomiting During Subarachnoid Anesthesia for Cesarean Section.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: G. d'Annunzio University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Perioperative nausea and vomiting may occur in 50-80% of patients undergoing cesarean section. Metoclopramide is a well known Dopamine receptor antagonist that acts at the Chemoreceptor trigger zone and is used effectively for the prevention and treatment of nausea and vomiting. Propofol can antagonize Serotonin receptors in the area postremal and is associated to a reduced incidence of postoperative nausea and vomiting. Some studies have shown that propofol can prevent intraoperative nausea and vomiting during cesarean section. The control of risk factors and the pharmacological prophylaxis of nausea and vomiting reduces effectively their incidence. In this randomized, double blind, case-control study the efficacy of propofol alone, metoclopramide alone and in combination in controlling nausea and vomiting were compared. A risk factor control strategy was associated to each study group.

Conditions

• PREGNANCY

Interventions

Type	Name	Description
DRUG	PROPOFOL	PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
DRUG	METOCLOPRAMIDE	METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
DRUG	PLACEBO	SALINE INFUSION

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2013-02-01
• Last updated: 2014-12-16

Locations

1 site across 1 country: Italy