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

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliera San Gerardo di Monza
Information provided by (Responsible Party):
Zhirajr Mokini, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier:
NCT01781377
First received: January 25, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
PREGNANCY
Drug: PROPOFOL
Drug: METOCLOPRAMIDE
Drug: PLACEBO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION MEASURED WITH VAS [ Time Frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS) ] [ Designated as safety issue: Yes ]
    INCIDENCE OF NAUSEA AND VOMITING


Secondary Outcome Measures:
  • ADVERSE EVENTS [ Time Frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS) ] [ Designated as safety issue: Yes ]
    HEADACHE, AGITATION, SEDATION.


Estimated Enrollment: 180
Study Start Date: February 2008
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROPOFOL
PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION
Drug: PROPOFOL
PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
Other Name: PROPOFOL
Experimental: METOCLOPRAMIDE
METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
Drug: METOCLOPRAMIDE
METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
Other Name: METOCLOPRAMIDE
Experimental: PROPOFOL & METOCLOPRAMIDE
PROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION
Drug: PROPOFOL
PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
Other Name: PROPOFOL
Drug: METOCLOPRAMIDE
METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
Other Name: METOCLOPRAMIDE
Placebo Comparator: PLACEBO
SALINE INFUSION
Drug: PLACEBO
SALINE INFUSION
Other Name: PLACEBO

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781377

Locations
Italy
A.O. SS.ma Annunziata
Chieti, Italy, 60100
Sponsors and Collaborators
G. d'Annunzio University
Azienda Ospedaliera San Gerardo di Monza
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
  More Information

No publications provided

Responsible Party: Zhirajr Mokini, M.D., Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT01781377     History of Changes
Other Study ID Numbers: 1632/08 COET
Study First Received: January 25, 2013
Last Updated: May 14, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by G. d'Annunzio University:
NAUSEA
VOMITING
CESAREAN SECTION
PREVENTION
PROPOFOL

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Propofol
Metoclopramide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014