- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781377
Prophylactic Subhypnotic Propofol for Nausea and Vomiting During for Cesarean Section Under Subarachnoid Anesthesia.
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Chieti, Italy, 60100
- A.O. SS.ma Annunziata
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
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
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dopamine Agents
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Hypnotics and Sedatives
- Propofol
- Metoclopramide
Other Study ID Numbers
- 1632/08 COET
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.
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