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

NCT ID: NCT01781377

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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PREGNANCY

Keywords

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NAUSEA VOMITING CESAREAN SECTION PREVENTION PROPOFOL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PROPOFOL

PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION

Group Type EXPERIMENTAL

PROPOFOL

Intervention Type DRUG

PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS

METOCLOPRAMIDE

METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION

Group Type EXPERIMENTAL

METOCLOPRAMIDE

Intervention Type DRUG

METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS

PROPOFOL & METOCLOPRAMIDE

PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION

Group Type EXPERIMENTAL

PROPOFOL

Intervention Type DRUG

PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS

METOCLOPRAMIDE

Intervention Type DRUG

METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS

PLACEBO

SALINE INFUSION

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

SALINE INFUSION

Interventions

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PROPOFOL

PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS

Intervention Type DRUG

METOCLOPRAMIDE

METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS

Intervention Type DRUG

PLACEBO

SALINE INFUSION

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role collaborator

G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Zhirajr Mokini

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ZHIRAJR MOKINI, M.D.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera San Gerardo di Monza

FLAVIA PETRINI, M.D.

Role: STUDY_DIRECTOR

University of Chieti

MICHELE SCESI, M.D.

Role: STUDY_DIRECTOR

University of Chieti

Locations

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A.O. SS.ma Annunziata

Chieti, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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1632/08 COET

Identifier Type: -

Identifier Source: org_study_id