NCT01781377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for phase_4 pregnancy

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

5.3 years

First QC Date

January 25, 2013

Last Update Submit

December 15, 2014

Conditions

PREGNANCY

Keywords

NAUSEAVOMITINGCESAREAN SECTIONPREVENTIONPROPOFOL

Outcome Measures

Primary Outcomes (1)

  • NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION

    INCIDENCE OF NAUSEA AND VOMITING

    FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)

Secondary Outcomes (1)

  • ADVERSE EVENTS

    FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)

Study Arms (4)

PROPOFOL

EXPERIMENTAL

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

Drug: PROPOFOL

METOCLOPRAMIDE

EXPERIMENTAL

METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION

Drug: METOCLOPRAMIDE

PROPOFOL & METOCLOPRAMIDE

EXPERIMENTAL

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

Drug: PROPOFOLDrug: METOCLOPRAMIDE

PLACEBO

PLACEBO COMPARATOR

SALINE INFUSION

Drug: PLACEBO

Interventions

PROPOFOLDRUG

PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS

PROPOFOLPROPOFOL & METOCLOPRAMIDE
METOCLOPRAMIDEDRUG

METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS

METOCLOPRAMIDEPROPOFOL & METOCLOPRAMIDE
PLACEBODRUG

SALINE INFUSION

PLACEBO

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CESAREAN SECTION WITHOUT MATERNAL OR FETAL SUFFERING
  • American Society of Anesthesiologists score I-II
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.O. SS.ma Annunziata

Chieti, Italy, 60100, Italy

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

PropofolMetoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzamidesAmidespara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsPhenyl Ethers

Study Officials

  • ZHIRAJR MOKINI, M.D.

    Azienda Ospedaliera San Gerardo di Monza

    PRINCIPAL INVESTIGATOR

  • FLAVIA PETRINI, M.D.

    University of Chieti

    STUDY DIRECTOR

  • MICHELE SCESI, M.D.

    University of Chieti

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 25, 2013

First Posted

February 1, 2013

Study Start

February 1, 2008

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

IT(1)