Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section
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| ClinicalTrials.gov Identifier: NCT00921102 |
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Recruitment Status :
Completed
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cesarean Section Anesthesia,Spinal Postoperative Nausea and Vomiting | Drug: Bupivacaine Drug: Morphine Drug: Isotonic saline solution Drug: Atropine | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 216 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Intrathecal Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia With Morphine for Elective Caesarean Section: a Randomized Controlled Trial |
| Study Start Date : | May 2007 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | May 2008 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Control
Patients in this group will receive both an intrathecal and intravenous injection of saline solution, as a placebo comparator.
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Drug: Bupivacaine
12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
Other Names:
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 Other Name: Sodium chloride |
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Experimental: 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.
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Drug: Bupivacaine
12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
Other Names:
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 Other Name: Sodium chloride Drug: Atropine 100 µg of a 1 mg/ml preservative-free solution
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Active Comparator: 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.
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Drug: Bupivacaine
12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally
Other Names:
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 Other Name: Sodium chloride Drug: Atropine 100 µg of a 1 mg/ml preservative-free solution
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- 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 ]
- 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 ]
- Incidence of atropine-related side effects such as xerostomia, anxiety, tachycardia. [ Time Frame: Up to 24 h postoperatively ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921102
| Italy | |
| University of Messina | |
| Messina, ME, Italy, 98122 | |
| University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma) | |
| Parma, PR, Italy, 43126 | |
| Study Chair: | Guido Fanelli, MD | University of Parma | |
| Principal Investigator: | Andrea Cornini, MD | Azienda Ospedaliero-Universitaria di Parma, Parma, Italy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Guido Fanelli, MD, University of Parma |
| ClinicalTrials.gov Identifier: | NCT00921102 |
| Other Study ID Numbers: |
ANEST-OST-01 |
| First Posted: | June 16, 2009 Key Record Dates |
| Last Update Posted: | June 16, 2009 |
| Last Verified: | June 2009 |
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Atropine Morphine Analgesics, Opioid Antiemetics |
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Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Atropine Morphine Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
Analgesics, Opioid Narcotics Analgesics Adjuvants, Anesthesia Anti-Arrhythmia Agents Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents |