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NCT Number: NCT00921102

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Messina, Messina, ME, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bupivacaine

Drug

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

Other names: Local Anesthetic, Hyperbaric Bupivacaine, Marcain Heavy Injection

Morphine

Drug

200 µg of a 200 µg/ml solution, intrathecally

Isotonic saline solution

Drug

0.9% NaCl solution

0.1 ml, intrathecally in group Control and IV Atropine

0.1 ml, intravenously in group Control and Intrathecal Atropine

Other names: Sodium chloride

Atropine

Drug

100 µg of a 1 mg/ml preservative-free solution

  • intrathecally in group Intrathecal Atropine
  • intravenously in group IV Atropine

Primary outcomes

  1. Incidence of postoperative nausea and vomiting (PONV) as expressed by at least one rating > 3 on a numerical rating scale (0-10).

    Time frame: 12 hours post-operatively

Secondary outcomes

  1. 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.

    Time frame: Up to 24 h postoperatively

  2. Incidence of atropine-related side effects such as xerostomia, anxiety, tachycardia.

    Time frame: Up to 24 h postoperatively

  3. Postoperative pain expressed as time to first request for supplemental analgesia and as rating on a numerical rating scale.

    Time frame: Up to 24 h postoperatively

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

Intrathecal Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia With Morphine for Elective Caesarean Section: a Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 16, 2009
Registry last updated
Jun 16, 2009

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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