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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00921102
Other study ID # ANEST-OST-01
Secondary ID
Status Completed
Phase Phase 4
First received June 15, 2009
Last updated June 15, 2009
Start date May 2007
Est. completion date May 2008

Study information

Verified date June 2009
Source University of Parma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Intrathecal (IT) morphine grants effective, durable and safe analgesia after Caesarean section. The most common adverse effects after IT morphine are widespread pruritus and postoperative nausea and vomiting (PONV).

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Italy University of Messina Messina ME
Italy University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma) Parma PR

Sponsors (1)

Lead Sponsor Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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

Outcome

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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