Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-04 @ 12:09 PM
Study NCT ID:
NCT01732666
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2012-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009340', 'term': 'Nefopam'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D010079', 'term': 'Oxazocines'}, {'id': 'D001392', 'term': 'Azocines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2012-11-18', 'studyFirstSubmitQcDate': '2012-11-23', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperalgesic extent around surgical incision', 'timeFrame': 'Postoperative 24 hr and 48 hr', 'description': 'The distance from the surgical incision to a point where patient does not feel pain when he gets stimuli with von Frey filament No.16 (122g/mm2).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid-induced hyperalgesia (OIH)'], 'conditions': ['Patients Undergoing Laparoscopic Gastrectomy']}, 'descriptionModule': {'briefSummary': 'Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was reported to occur after surgery when large amount of remifentanil was administered. On the other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to have analgesic and anti-hyperalgesic effect.\n\nThe investigators hypothesized that nefopam administration could prevent OIH or reduce the severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing laparoscopic gastrectomy\n2. American Society of Anesthesiologists physical status I or II\n3. aged from 20 to 65 years\n\nExclusion Criteria:\n\n1. Past history of chronic pain\n2. Drug or alcohol abuse\n3. Psychotic disorder\n4. Taking analgesics, anti-epileptics, and anti-depressants.\n5. Taking opioids within 24 hrs\n6. Renal disease\n7. Neuromuscular disease.\n8. Moderate to severe cardiovascular disease\n9. Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT01732666', 'briefTitle': 'Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2011-0883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group L', 'description': 'receives 100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.', 'interventionNames': ['Drug: low dose remifentanil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group H', 'description': '100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.', 'interventionNames': ['Drug: high dose remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'group N', 'description': '20mg of nefopam mixed in 100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.', 'interventionNames': ['Drug: Nefopam']}], 'interventions': [{'name': 'Nefopam', 'type': 'DRUG', 'description': '20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.', 'armGroupLabels': ['group N']}, {'name': 'low dose remifentanil', 'type': 'DRUG', 'description': '100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.', 'armGroupLabels': ['group L']}, {'name': 'high dose remifentanil', 'type': 'DRUG', 'description': '100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.', 'armGroupLabels': ['group H']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}