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

Study Overview
=================
Brief 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.

Official Title
-----------------
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.

Conditions
-----------------
PREGNANCY

Intervention / Treatment
-----------------
* Drug: PROPOFOL
* Drug: METOCLOPRAMIDE
* Drug: PLACEBO


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROPOFOL<br>PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION | Drug: PROPOFOL<br>* PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS<br>|
| Experimental: METOCLOPRAMIDE<br>METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION | Drug: METOCLOPRAMIDE<br>* METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS<br>|
| Experimental: PROPOFOL & METOCLOPRAMIDE<br>PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION | Drug: PROPOFOL<br>* PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS<br>Drug: METOCLOPRAMIDE<br>* METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS<br>|
| Placebo Comparator: PLACEBO<br>SALINE INFUSION | Drug: PLACEBO<br>* SALINE INFUSION<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION | INCIDENCE OF NAUSEA AND VOMITING | FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADVERSE EVENTS | HEADACHE, AGITATION, SEDATION. | FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAUSEA, VOMITING, CESAREAN SECTION, PREVENTION, PROPOFOL