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Completed

NCT Number: NCT01781377

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

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.

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Key information

Conditions

Pregnancy Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

A.O. SS.ma Annunziata

Chieti, Italy, 60100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS

Metoclopramide

Drug

METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS

Placebo

Drug

SALINE INFUSION

Primary outcomes

  1. NAUSEA AND VOMITING ASSOCIATED WITH CESAREAN SECTION

    Time frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)

    INCIDENCE OF NAUSEA AND VOMITING

Secondary outcomes

  1. ADVERSE EVENTS

    Time frame: FROM ANESTHESIA TO THE END OF SURGERY (AVERAGE 2 HOURS)

    HEADACHE, AGITATION, SEDATION.

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Collaborators

  • Azienda Ospedaliera San Gerardo di Monza

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2013
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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