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

PREGNANCY Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781377
• Other study ID #: 1632/08 COET
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2013
• Last updated: December 15, 2014
• Start date: February 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• PREGNANCY
• Vomiting

Intervention

Drug:
• PROPOFOL
PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
• METOCLOPRAMIDE
METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
• PLACEBO
SALINE INFUSION

Locations

Country	Name	City	State
Italy	A.O. SS.ma Annunziata	Chieti

Sponsors (2)

Lead Sponsor	Collaborator
G. d'Annunzio University	Azienda Ospedaliera San Gerardo di Monza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION	INCIDENCE OF NAUSEA AND VOMITING	FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)	Yes
Secondary	ADVERSE EVENTS	HEADACHE, AGITATION, SEDATION.	FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)	Yes