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

Primary Purpose

PREGNANCY

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
PROPOFOL
METOCLOPRAMIDE
PLACEBO
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PREGNANCY focused on measuring NAUSEA, VOMITING, CESAREAN SECTION, PREVENTION, PROPOFOL

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • A.O. SS.ma Annunziata

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

PROPOFOL

METOCLOPRAMIDE

PROPOFOL & METOCLOPRAMIDE

PLACEBO

Arm Description

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

METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION

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

SALINE INFUSION

Outcomes

Primary Outcome Measures

NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
INCIDENCE OF NAUSEA AND VOMITING

Secondary Outcome Measures

ADVERSE EVENTS
HEADACHE, AGITATION, SEDATION.

Full Information

First Posted
January 25, 2013
Last Updated
December 15, 2014
Sponsor
G. d'Annunzio University
Collaborators
Azienda Ospedaliera San Gerardo di Monza
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1. Study Identification

Unique Protocol Identification Number
NCT01781377
Brief Title
Prophylactic Subhypnotic Propofol for Nausea and Vomiting During for Cesarean Section Under Subarachnoid Anesthesia.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University
Collaborators
Azienda Ospedaliera San Gerardo di Monza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PREGNANCY
Keywords
NAUSEA, VOMITING, CESAREAN SECTION, PREVENTION, PROPOFOL

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PROPOFOL
Arm Type
Experimental
Arm Description
PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION
Arm Title
METOCLOPRAMIDE
Arm Type
Experimental
Arm Description
METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
Arm Title
PROPOFOL & METOCLOPRAMIDE
Arm Type
Experimental
Arm Description
PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
SALINE INFUSION
Intervention Type
Drug
Intervention Name(s)
PROPOFOL
Intervention Description
PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
Intervention Type
Drug
Intervention Name(s)
METOCLOPRAMIDE
Intervention Description
METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
SALINE INFUSION
Primary Outcome Measure Information:
Title
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
Description
INCIDENCE OF NAUSEA AND VOMITING
Time Frame
FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
Secondary Outcome Measure Information:
Title
ADVERSE EVENTS
Description
HEADACHE, AGITATION, SEDATION.
Time Frame
FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZHIRAJR MOKINI, M.D.
Organizational Affiliation
Azienda Ospedaliera San Gerardo di Monza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FLAVIA PETRINI, M.D.
Organizational Affiliation
University of Chieti
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
MICHELE SCESI, M.D.
Organizational Affiliation
University of Chieti
Official's Role
Study Director
Facility Information:
Facility Name
A.O. SS.ma Annunziata
City
Chieti
ZIP/Postal Code
60100
Country
Italy

12. IPD Sharing Statement

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

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