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

Phase 4

Completed

• Conditions: PREGNANCY
• Interventions: Drug: PLACEBO; Drug: METOCLOPRAMIDE; Drug: PROPOFOL

• Registration Number: NCT01781377
• Lead Sponsor: G. d'Annunzio University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-02-01
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	PLACEBO	SALINE INFUSION
METOCLOPRAMIDE	METOCLOPRAMIDE	METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
PROPOFOL	PROPOFOL	PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION
PROPOFOL & METOCLOPRAMIDE	PROPOFOL	PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
PROPOFOL & METOCLOPRAMIDE	METOCLOPRAMIDE	PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION

Primary Outcome Measures

Name	Time	Method
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION	FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)	INCIDENCE OF NAUSEA AND VOMITING

Secondary Outcome Measures

Name	Time	Method
ADVERSE EVENTS	FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)	HEADACHE, AGITATION, SEDATION.

Trial Locations

Locations (1)

A.O. SS.ma Annunziata; 🇮🇹 Chieti, Italy