Cesarean Section Clinical Trial
Official title:
Intrathecal Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia With Morphine for Elective Caesarean Section: a Randomized Controlled Trial
Verified date | June 2009 |
Source | University of Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 216 |
Est. completion date | May 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients scheduled for elective Cesarean section at up to 42 weeks and 2 days - Patients in ASA Physical Status Class I or II - Informed written consent to participation - No known gestosis Exclusion Criteria: - Any known fetal pathology - Indication to general anesthesia - Known allergy to any of the study drugs - Baseline bradycardia or any cardiovascular disease |
Country | Name | City | State |
---|---|---|---|
Italy | University of Messina | Messina | ME |
Italy | University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma) | Parma | PR |
Lead Sponsor | Collaborator |
---|---|
University of Parma |
Italy,
Kotelko DM, Rottman RL, Wright WC, Stone JJ, Yamashiro AY, Rosenblatt RM. Transdermal scopolamine decreases nausea and vomiting following cesarean section in patients receiving epidural morphine. Anesthesiology. 1989 Nov;71(5):675-8. — View Citation
Moscovici R, Prego G, Schwartz M, Steinfeld O. Epidural scopolamine administration in preventing nausea after epidural morphine. J Clin Anesth. 1995 Sep;7(6):474-6. — View Citation
Ramaioli F, De Amici D. Central antiemetic effect of atropine: our personal experience. Can J Anaesth. 1996 Oct;43(10):1079. — View Citation
Salmenperä M, Kuoppamäki R, Salmenperä A. Do anticholinergic agents affect the occurrence of postanaesthetic nausea? Acta Anaesthesiol Scand. 1992 Jul;36(5):445-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of postoperative nausea and vomiting (PONV) as expressed by at least one rating > 3 on a numerical rating scale (0-10). | 12 hours post-operatively | ||
Secondary | Incidence and prevalence of PONV up to 24 h postoperatively, expressed as both ratings on a numerical rating scale and as the area under the curve of these ratings over time. | Up to 24 h postoperatively | ||
Secondary | Incidence of atropine-related side effects such as xerostomia, anxiety, tachycardia. | Up to 24 h postoperatively | ||
Secondary | Postoperative pain expressed as time to first request for supplemental analgesia and as rating on a numerical rating scale. | Up to 24 h postoperatively |
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