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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G. d'Annunzio University
• Collaborator: Azienda Ospedaliera San Gerardo di Monza
• Treatments: Metoclopramide; Propofol

Criteria

Inclusion Criteria:

CESAREAN SECTION WITHOUT MATERNAL OR FETAL SUFFERING

American Society of Anesthesiologists score I-II

36 TO 41 WEEK OF GESTATION

BMI < 35

HEMOGLOBIN > 10 mg/dl

NO COMPLICATIONS (GESTATIONAL DIABETES, COLESTASIS)

NO ACUTE OR CHRONIC GASTROINTESTINAL DISORDERS (GERD excluded)

NO SMOKING OR DRUG ABUSE DURING PREGNANCY

NO PREVIOUS MAJOR ABDOMINAL SURGERY

NO PREVIOUS COMPLICATED PREGNANCIES

FETAL WEIGHT > 2.5 kg

Exclusion Criteria:

EMERGENCY CESAREAN SECTION WITH MATERNAL OR FETAL SUFFERING

American Society of Anesthesiologists score III-IV-V

< 36 OR > 41 WEEK OF GESTATION

BMI > 35

HEMOGLOBIN < 10 mg/dl

COMPLICATIONS (GESTATIONAL DIABETES, COLESTASIS)

ACUTE OR CHRONIC GASTROINTESTINAL DISORDERS

SMOKING OR DRUG ABUSE DURING PREGNANCY

PREVIOUS MAJOR ABDOMINAL SURGERY

PREVIOUS COMPLICATED PREGNANCIES

FETAL WEIGHT < 2.5 kg