Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 11:19 AM
Study NCT ID:
NCT01571804
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2012-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregabalin Reduce the Sevoflurane Requirement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2012-03-31', 'studyFirstSubmitQcDate': '2012-04-03', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in the end tidal sevoflurane concentrations', 'timeFrame': 'intraoperative every 15 min', 'description': 'End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure.'}], 'secondaryOutcomes': [{'measure': 'hemodynamic parameters', 'timeFrame': 'before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery', 'description': 'heart rate and mean arterial blood pressure were recorded before (baseline), 45 min after the administration of the study capsules; every 15 min after intubation until the skin closure and every 15 min for the first hour after extubation.'}, {'measure': 'intraoperative fentanyl supplementations', 'timeFrame': 'intraoperative, an expected average of 2 hours', 'description': 'intraoperative fentanyl supplementations'}, {'measure': 'quality of tracheal extubation', 'timeFrame': 'up to 24 after surgery', 'description': 'The quality of tracheal extubation was evaluated using a 5 - points rating scale: 1, no coughing or straining; 2, very smooth, minimal coughing; 3, moderate coughing; 4, marked coughing or straining; and 5, poor extubation, very uncomfortable'}, {'measure': 'postoperative cumulative morphine consumption', 'timeFrame': 'up to 24 after surgery', 'description': 'postoperative cumulative morphine consumption'}, {'measure': 'postoperative sedation and pain scores', 'timeFrame': 'up to 24 after surgery', 'description': 'Postoperative pain VAS scores sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep)'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': 'up to 24 after surgery', 'description': 'nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting)'}, {'measure': 'awareness and recall', 'timeFrame': 'intraoperative, an expected average of 2 hours', 'description': 'The patients were asked about intraoperative awareness and recall on the second postoperative day by asking three simple questions using standard interview "What was the last thing you remembered happening before you went to sleep? What is the first thing you remember happening on waking? Did you dream or have any other experiences whilst you were asleep?"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anesthesia', 'pregabalin', 'sevoflurane', 'laparoscopic cholecystectomy'], 'conditions': ['Elective Laparoscopic Cholecystectomy', 'Sevoflurane Anesthesia']}, 'descriptionModule': {'briefSummary': 'Preoperative administration of pregabalin would reduce the end tidal concentration of sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the quality of postoperative analgesia.', 'detailedDescription': 'laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the presynaptic voltage-gated calcium channels that are widely distributed throughout the central and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating, anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin, dopamine and substance P. These unique characteristics make pregabalin as a useful therapeutic for treating neuropathic pain and acute postoperative pain in several models of incisional injury and inflammatory conditions including laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists class I and II\n* scheduled for elective laparoscopic cholecystectomy\n* under sevoflurane anesthesia\n\nExclusion Criteria:\n\n* communication barriers\n* cardiovascular diseases\n* renal diseases\n* hepatic diseases\n* endocrinal diseases\n* neuropsychiatric diseases\n* prolonged P-R interval\n* pregnancy\n* nursing\n* hypersensitivity\n* treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week'}, 'identificationModule': {'nctId': 'NCT01571804', 'briefTitle': 'Pregabalin Reduce the Sevoflurane Requirement', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.', 'orgStudyIdInfo': {'id': 'R/49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pregabalin 150 mg group', 'description': 'one capsule of pregabalin 150 mg and one placebo capsule', 'interventionNames': ['Drug: pregabalin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pregabalin 300 mg group', 'description': 'two capsules of pregabalin 150 mg', 'interventionNames': ['Drug: pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'to receive two identical placebo capsules', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'to receive two identical placebo capsules 1 hr before surgery', 'armGroupLabels': ['placebo group']}, {'name': 'pregabalin', 'type': 'DRUG', 'description': 'one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery', 'armGroupLabels': ['pregabalin 150 mg group']}, {'name': 'pregabalin', 'type': 'DRUG', 'description': 'two capsules of pregabalin 150 mg 1 hr before surgery', 'armGroupLabels': ['pregabalin 300 mg group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed R El Tahan', 'investigatorAffiliation': 'Mansoura University'}}}}