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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2010-07-07', 'studyFirstSubmitQcDate': '2010-07-07', 'lastUpdatePostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propofol induction dose', 'timeFrame': '1 hour', 'description': 'Evaluation of the hpreoperative pregabalin Vs placebo effect on propofol induction dose needed to induce general anesthesia assessed by entropy in gynaecologic patients undertaking minor surgical procedure.'}], 'secondaryOutcomes': [{'measure': 'Preoperative anxiety', 'timeFrame': '1 hour', 'description': 'Evaluation of the effect of pregabalin Vs placebo on preoperative anxiety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia, General', 'Propofol', 'Pregabalin', 'Preoperative care', 'Laparoscopic surgery'], 'conditions': ['Anesthesia, General', 'Laparoscopic Surgery']}, 'referencesModule': {'references': [{'pmid': '18042886', 'type': 'BACKGROUND', 'citation': 'Gajraj NM. Pregabalin: its pharmacology and use in pain management. Anesth Analg. 2007 Dec;105(6):1805-15. doi: 10.1213/01.ane.0000287643.13410.5e.'}, {'pmid': '17873599', 'type': 'BACKGROUND', 'citation': 'Gilron I. Gabapentin and pregabalin for chronic neuropathic and early postsurgical pain: current evidence and future directions. Curr Opin Anaesthesiol. 2007 Oct;20(5):456-72. doi: 10.1097/ACO.0b013e3282effaa7.'}, {'pmid': '16376147', 'type': 'BACKGROUND', 'citation': 'Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006 Feb;6(1):108-13. doi: 10.1016/j.coph.2005.11.003. Epub 2005 Dec 22.'}, {'pmid': '16765030', 'type': 'BACKGROUND', 'citation': 'Kavoussi R. Pregabalin: From molecule to medicine. Eur Neuropsychopharmacol. 2006 Jul;16 Suppl 2:S128-33. doi: 10.1016/j.euroneuro.2006.04.005. Epub 2006 Jun 9.'}, {'pmid': '11465977', 'type': 'BACKGROUND', 'citation': 'Hill CM, Balkenohl M, Thomas DW, Walker R, Mathe H, Murray G. Pregabalin in patients with postoperative dental pain. Eur J Pain. 2001;5(2):119-24. doi: 10.1053/eujp.2001.0235.'}, {'pmid': '18653493', 'type': 'BACKGROUND', 'citation': 'Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23.'}, {'pmid': '18448418', 'type': 'BACKGROUND', 'citation': 'Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. doi: 10.1093/bja/aen098. Epub 2008 Apr 29.'}, {'pmid': '17507163', 'type': 'BACKGROUND', 'citation': 'Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.'}, {'pmid': '17959981', 'type': 'BACKGROUND', 'citation': 'Paech MJ, Goy R, Chua S, Scott K, Christmas T, Doherty DA. A randomized, placebo-controlled trial of preoperative oral pregabalin for postoperative pain relief after minor gynecological surgery. Anesth Analg. 2007 Nov;105(5):1449-53, table of contents. doi: 10.1213/01.ane.0000286227.13306.d7.'}, {'pmid': '18006529', 'type': 'BACKGROUND', 'citation': 'Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.'}, {'pmid': '16805934', 'type': 'BACKGROUND', 'citation': 'Memis D, Turan A, Karamanlioglu B, Seker S, Ture M. Gabapentin reduces cardiovascular responses to laryngoscopy and tracheal intubation. Eur J Anaesthesiol. 2006 Aug;23(8):686-90. doi: 10.1017/S0265021506000500.'}, {'pmid': '16595614', 'type': 'BACKGROUND', 'citation': 'Fassoulaki A, Melemeni A, Paraskeva A, Petropoulos G. Gabapentin attenuates the pressor response to direct laryngoscopy and tracheal intubation. Br J Anaesth. 2006 Jun;96(6):769-73. doi: 10.1093/bja/ael076. Epub 2006 Apr 4.'}, {'pmid': '15845693', 'type': 'BACKGROUND', 'citation': 'Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.'}, {'pmid': '16634416', 'type': 'BACKGROUND', 'citation': 'Johansen JW. Update on bispectral index monitoring. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):81-99. doi: 10.1016/j.bpa.2005.08.004.'}, {'pmid': '16634417', 'type': 'BACKGROUND', 'citation': 'Bein B. Entropy. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):101-9. doi: 10.1016/j.bpa.2005.07.009.'}, {'pmid': '17513656', 'type': 'BACKGROUND', 'citation': 'Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.'}, {'pmid': '23334782', 'type': 'DERIVED', 'citation': 'Moreau-Bussiere F, Gaulin J, Gagnon V, Sansoucy Y, de Medicis E. Preoperative pregabalin does not reduce propofol ED(50): a randomized controlled trial. Can J Anaesth. 2013 Apr;60(4):364-9. doi: 10.1007/s12630-013-9885-y. Epub 2013 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'The primary issue is to determine whether preoperatively administered pregabalin decreases the necessary dose of propofol during induction of general anesthesia. The investigators secondary issue is to test if preoperatively administered pregabalin decreases anxiety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laparoscopic gynaecologic surgery\n* Age 18-40 years\n* ASA class I or II\n* Body mass index 18-30\n\nExclusion Criteria:\n\n* Allergic to pregabalin or gabapentin\n* Chronic renal failure\n* Alcohol or drug abuse\n* Chronic analgesic use other than acetaminophen or NSAID\n* Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug\n* Known neurological deficiency\n* Suspected difficult intubation or ventilation\n* Atypical pseudocholinesterases'}, 'identificationModule': {'nctId': 'NCT01158859', 'briefTitle': 'Effect of Preoperative Pregabalin on Propofol Induction Dose', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Effect of Preoperative Pregabalin on Propofol Induction Dose', 'orgStudyIdInfo': {'id': 'CRC09-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregabalin', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Preoperative administration of pregabalin vs placebo 1 hour before surgery', 'armGroupLabels': ['Placebo', 'Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Etienne de Medicis, MD MSc FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Etienne de Medicis', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}