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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01781377

Enrollment

112

Registered

2013-02-01

Start date

2008-02-29

Completion date

2013-12-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PREGNANCY

Keywords

NAUSEA, VOMITING, CESAREAN SECTION, PREVENTION, PROPOFOL

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.

Interventions

DRUGPROPOFOL

PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS

DRUGMETOCLOPRAMIDE

METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS

DRUGPLACEBO

SALINE INFUSION

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION	FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)	INCIDENCE OF NAUSEA AND VOMITING

Secondary

Measure	Time frame	Description
ADVERSE EVENTS	FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)	HEADACHE, AGITATION, SEDATION.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026