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

December 15, 2014 updated by: Zhirajr Mokini, G. d'Annunzio University

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chieti, Italy, 60100
        • A.O. SS.ma Annunziata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PROPOFOL
PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION
PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
EXPERIMENTAL: METOCLOPRAMIDE
METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
EXPERIMENTAL: PROPOFOL & METOCLOPRAMIDE
PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
PLACEBO_COMPARATOR: PLACEBO
SALINE INFUSION
SALINE INFUSION

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
Time Frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
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
Time Frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
HEADACHE, AGITATION, SEDATION.
FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ZHIRAJR MOKINI, M.D., Azienda Ospedaliera San Gerardo di Monza
  • Study Director: FLAVIA PETRINI, M.D., University of Chieti
  • Study Director: MICHELE SCESI, M.D., University of Chieti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (ESTIMATE)

February 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PREGNANCY

Clinical Trials on PROPOFOL

3
Subscribe