Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section
NCT ID: NCT00921102
Last Updated: 2009-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
216 participants
INTERVENTIONAL
2007-05-31
2008-05-31
Brief Summary
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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.
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Detailed Description
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Postoperative nausea and vomiting is multifactorial in origin; in addition to general and pre-existing risk factors, such as elevated gonadotropin and progesterone serum levels, parturients undergoing Caesarean section are exposed to drug-induced, hemodynamic and surgical (manipulation of the uterus) stimuli.
Anticholinergic agents, and particularly scopolamine, have long been known to decrease opioid-related nausea and vomiting, although their narrow therapeutic range and inconvenient route of administration (typically transdermal) has limited their application. Anticholinergic agents are thought to act via inhibition of muscarinic receptors in several regions of the medulla oblongata, which are implicated with nausea and vomiting generation; in addition to the chemoceptor trigger zone, these receptors are particularly concentrated in, but not limited to the nucleus tractus solitarius. Cholinergic receptors have been typically associated with motion sickness, but cholinergic agonists such as neostigmine have been shown to increase the incidence of PONV, especially when injected intrathecally.
Anticholinergic agents with muscarinic selectivity may be effective in preventing and treating PONV. Intravenous (IV) administration of scopolamine or atropine, but not glycopyrrolate, reduces the incidence of PONV. Intuitively, as glycopyrrolate does not cross the blood-brain barrier, most postoperative anti-emetic effects of anticholinergic drugs should be mediated by central receptors.
Few studies have specifically evaluated the antiemetic effect of IV atropine after balanced general or opioid-based regional anesthesia, with conflicting results. Atropine may represent a valid alternative to scopolamine and its adverse effects; however, its apparent duration of action is "brief" (minutes to 1 hour) when administered IV.
After we became aware of several observations by Ramaioli and De Amici on the efficacy of small-dose intrathecal (IT) atropine for the treatment of PONV after IT morphine administration, we set out to investigate the use of this agent for prophylaxis of PONV in a high-risk population, such as patients receiving IT morphine for postoperative analgesia after elective Caesarean section.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
Patients in this group will receive both an intrathecal and intravenous injection of saline solution, as a placebo comparator.
Bupivacaine
12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
Morphine
200 µg of a 200 µg/ml solution, intrathecally
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
Intrathecal Atropine
Patients in this group will receive intrathecal atropine as a prophylactic antiemetic agent. They will also receive intravenous saline solution to maintain blinding.
Bupivacaine
12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
Morphine
200 µg of a 200 µg/ml solution, intrathecally
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
Atropine
100 µg of a 1 mg/ml preservative-free solution
* intrathecally in group Intrathecal Atropine
* intravenously in group IV Atropine
IV Atropine
Patients in this group will receive a small dose of atropine via the intravenous route to examine its possible antiemetic activity. They will also receive intravenous saline solution to maintain blinding.
Bupivacaine
12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
Morphine
200 µg of a 200 µg/ml solution, intrathecally
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
Atropine
100 µg of a 1 mg/ml preservative-free solution
* intrathecally in group Intrathecal Atropine
* intravenously in group IV Atropine
Interventions
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Bupivacaine
12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
Morphine
200 µg of a 200 µg/ml solution, intrathecally
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
Atropine
100 µg of a 1 mg/ml preservative-free solution
* intrathecally in group Intrathecal Atropine
* intravenously in group IV Atropine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients in ASA Physical Status Class I or II
* Informed written consent to participation
* No known gestosis
Exclusion Criteria
* Indication to general anesthesia
* Known allergy to any of the study drugs
* Baseline bradycardia or any cardiovascular disease
18 Years
FEMALE
No
Sponsors
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University of Parma
OTHER
Responsible Party
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University of Parma
Principal Investigators
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Guido Fanelli, MD
Role: STUDY_CHAIR
University of Parma
Andrea Cornini, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
Locations
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University of Messina
Messina, ME, Italy
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, PR, Italy
Countries
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References
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Ramaioli F, De Amici D. Central antiemetic effect of atropine: our personal experience. Can J Anaesth. 1996 Oct;43(10):1079. doi: 10.1007/BF03011915. No abstract available.
Salmenpera M, Kuoppamaki R, Salmenpera A. Do anticholinergic agents affect the occurrence of postanaesthetic nausea? Acta Anaesthesiol Scand. 1992 Jul;36(5):445-8. doi: 10.1111/j.1399-6576.1992.tb03494.x.
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. doi: 10.1016/0952-8180(95)00056-n.
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. doi: 10.1097/00000542-198911000-00009.
Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
Other Identifiers
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ANEST-OST-01
Identifier Type: -
Identifier Source: org_study_id
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