PREGNANCYPhase 4NCT01781377
Prophylactic Subhypnotic Propofol for Nausea and Vomiting During for Cesarean Section Under Subarachnoid Anesthesia.
A Phase 4 study testing PROPOFOL and METOCLOPRAMIDE in people with PREGNANCY, run by G. d'Annunzio University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- PREGNANCY
- What is being tested?
- PROPOFOL and METOCLOPRAMIDE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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)
Show all 11Show fewer
- ACUTE OR CHRONIC GASTROINTESTINAL DISORDERS
- SMOKING OR DRUG ABUSE DURING PREGNANCY
- PREVIOUS MAJOR ABDOMINAL SURGERY
- PREVIOUS COMPLICATED PREGNANCIES
- FETAL WEIGHT < 2.5 kg
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROPOFOLDrug
PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
METOCLOPRAMIDEDrug
METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
PLACEBODrug
SALINE INFUSION
| Study group | Role | What they receive |
|---|---|---|
| PROPOFOL | Experimental | PROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION Receives: Drug: PROPOFOL |
| METOCLOPRAMIDE | Experimental | METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION Receives: 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 Receives: Drug: PROPOFOL; Drug: METOCLOPRAMIDE |
| PLACEBO | Placebo comparator | SALINE INFUSION Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
INCIDENCE OF NAUSEA AND VOMITING
Measured: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
Secondary outcomes (1)
ADVERSE EVENTS
HEADACHE, AGITATION, SEDATION.
Measured: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startFeb 2008
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREGNANCYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza
- Responsible party
- Principal investigator, Zhirajr Mokini, Azienda Ospedaliera San Gerardo di Monza
- Investigators
- ZHIRAJR MOKINI, M.D., Principal investigator, Azienda Ospedaliera San Gerardo di MonzaFLAVIA PETRINI, M.D., Study director, University of ChietiMICHELE SCESI, M.D., Study director, University of Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781377
- Sponsor's protocol ID
- 1632/08 COET
- Status last verified
- Dec 2014
- First submitted
- 25 Jan 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01781377
- Acronym / sponsor ID
- 1632/08 COET
- Conditions
- PREGNANCY
- Keywords
- NAUSEA, VOMITING, CESAREAN SECTION, PREVENTION, PROPOFOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza
- Study start
- Feb 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PROPOFOL | Experimental | Drug: PROPOFOLPROPOFOL SINGLE BOLUS 10 mg + 1mg/kg/hr INFUSION AT UMBILICAL CORD RESECTION |
| METOCLOPRAMIDE | Experimental | Drug: METOCLOPRAMIDEMETOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION |
| PROPOFOL & METOCLOPRAMIDE | Experimental | Drug: PROPOFOL, Drug: METOCLOPRAMIDEPROPOFOL SINGLE BOLUS of 10 mg + 1mg/kg/hr INFUSION AND METOCLOPRAMIDE 10 mg I.V. AT UMBILICAL CORD RESECTION |
| PLACEBO | Placebo comparator | Drug: PLACEBOSALINE INFUSION |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROPOFOLPROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS | Drug | PROPOFOL, PROPOFOL & METOCLOPRAMIDE |
| METOCLOPRAMIDEMETOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS | Drug | METOCLOPRAMIDE, PROPOFOL & METOCLOPRAMIDE |
| PLACEBOSALINE INFUSION | Drug | PLACEBO |
Primary outcome
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
Time frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
INCIDENCE OF NAUSEA AND VOMITING
1 secondary outcome
ADVERSE EVENTS
Time frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
Related trials for PREGNANCY
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZHIRAJR MOKINI, M.D. principal investigator
Azienda Ospedaliera San Gerardo di Monza
FLAVIA PETRINI, M.D. study director
University of Chieti
MICHELE SCESI, M.D. study director
University of Chieti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PROPOFOL and METOCLOPRAMIDE in people with PREGNANCY, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION (time frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.