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Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section

NCT00921102 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2009-06-16

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting after spinal anesthesia with local anesthetic and morphine for elective Caesarean section.

Patients enrolling in the study will be assigned to one of three groups. One will receive a small dose of intrathecal atropine; another will receive small-dose intravenous atropine; the third group will receive placebo.

Conditions

  • Cesarean Section
  • Anesthesia,Spinal
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Bupivacaine

12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally

DRUG

Morphine

200 µg of a 200 µg/ml solution, intrathecally

DRUG

Isotonic saline solution

0.9% NaCl solution 0.1 ml, intrathecally in group Control and IV Atropine 0.1 ml, intravenously in group Control and Intrathecal Atropine

DRUG

Atropine

100 µg of a 1 mg/ml preservative-free solution * intrathecally in group Intrathecal Atropine * intravenously in group IV Atropine

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Principal Investigators

  • Guido Fanelli, MD · University of Parma

  • Andrea Cornini, MD · Azienda Ospedaliero-Universitaria di Parma, Parma, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-02-29
Completion
2008-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00921102 on ClinicalTrials.gov