Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00921102
Status:
COMPLETED
Last Update Posted:
2009-06-16
First Post:
2009-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-10', 'releaseDate': '2011-07-14'}, {'resetDate': '2012-02-02', 'releaseDate': '2012-01-05'}, {'resetDate': '2013-12-23', 'releaseDate': '2013-11-02'}], 'estimatedResultsFirstSubmitDate': '2011-07-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-15', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting (PONV) as expressed by at least one rating > 3 on a numerical rating scale (0-10).', 'timeFrame': '12 hours post-operatively'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Up to 24 h postoperatively'}, {'measure': 'Incidence of atropine-related side effects such as xerostomia, anxiety, tachycardia.', 'timeFrame': 'Up to 24 h postoperatively'}, {'measure': 'Postoperative pain expressed as time to first request for supplemental analgesia and as rating on a numerical rating scale.', 'timeFrame': 'Up to 24 h postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atropine', 'Morphine', 'Analgesics, Opioid', 'Antiemetics'], 'conditions': ['Cesarean Section', 'Anesthesia,Spinal', 'Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '8896865', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1632167', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8534463', 'type': 'BACKGROUND', '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. doi: 10.1016/0952-8180(95)00056-n.'}, {'pmid': '2817461', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34002866', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.', 'detailedDescription': '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).\n\nPostoperative 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.\n\nAnticholinergic 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.\n\nAnticholinergic 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.\n\nFew 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective Cesarean section at up to 42 weeks and 2 days\n* Patients in ASA Physical Status Class I or II\n* Informed written consent to participation\n* No known gestosis\n\nExclusion Criteria:\n\n* Any known fetal pathology\n* Indication to general anesthesia\n* Known allergy to any of the study drugs\n* Baseline bradycardia or any cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT00921102', 'briefTitle': 'Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Intrathecal Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia With Morphine for Elective Caesarean Section: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ANEST-OST-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients in this group will receive both an intrathecal and intravenous injection of saline solution, as a placebo comparator.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Morphine', 'Drug: Isotonic saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'Intrathecal Atropine', 'description': 'Patients in this group will receive intrathecal atropine as a prophylactic antiemetic agent. They will also receive intravenous saline solution to maintain blinding.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Morphine', 'Drug: Isotonic saline solution', 'Drug: Atropine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Atropine', 'description': '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.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Morphine', 'Drug: Isotonic saline solution', 'Drug: Atropine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Local Anesthetic', 'Hyperbaric Bupivacaine', 'Marcain Heavy Injection'], 'description': '12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally', 'armGroupLabels': ['Control', 'IV Atropine', 'Intrathecal Atropine']}, {'name': 'Morphine', 'type': 'DRUG', 'description': '200 µg of a 200 µg/ml solution, intrathecally', 'armGroupLabels': ['Control', 'IV Atropine', 'Intrathecal Atropine']}, {'name': 'Isotonic saline solution', 'type': 'DRUG', 'otherNames': ['Sodium chloride'], 'description': '0.9% NaCl solution\n\n0.1 ml, intrathecally in group Control and IV Atropine\n\n0.1 ml, intravenously in group Control and Intrathecal Atropine', 'armGroupLabels': ['Control', 'IV Atropine', 'Intrathecal Atropine']}, {'name': 'Atropine', 'type': 'DRUG', 'description': '100 µg of a 1 mg/ml preservative-free solution\n\n* intrathecally in group Intrathecal Atropine\n* intravenously in group IV Atropine', 'armGroupLabels': ['IV Atropine', 'Intrathecal Atropine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98122', 'city': 'Messina', 'state': 'ME', 'country': 'Italy', 'facility': 'University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '43126', 'city': 'Parma', 'state': 'PR', 'country': 'Italy', 'facility': 'University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Guido Fanelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Parma'}, {'name': 'Andrea Cornini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero-Universitaria di Parma, Parma, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guido Fanelli, MD', 'oldOrganization': 'University of Parma'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-14', 'type': 'RELEASE'}, {'date': '2011-08-10', 'type': 'RESET'}, {'date': '2012-01-05', 'type': 'RELEASE'}, {'date': '2012-02-02', 'type': 'RESET'}, {'date': '2013-11-02', 'type': 'RELEASE'}, {'date': '2013-12-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Guido Fanelli, Professor of Anesthesiology and Critical Care, University of Parma'}}}}