Clinical trial NCT01781377: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: PREGNANCY
Keywords: NAUSEA
VOMITING
CESAREAN SECTION
PREVENTION
PROPOFOL
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera San Gerardo di Monza
First posted: 2013-02-01
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION
timeFrame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
Secondary outcomes:
measure: ADVERSE EVENTS
timeFrame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: A.O. SS.ma Annunziata
Study officials:
affiliation: Azienda Ospedaliera San Gerardo di Monza
name: ZHIRAJR MOKINI, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chieti
name: FLAVIA PETRINI, M.D.
role: STUDY_DIRECTOR
affiliation: University of Chieti
name: MICHELE SCESI, M.D.
role: STUDY_DIRECTOR
References: