Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 8:54 AM
Study NCT ID:
NCT03735368
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2018-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'C005298', 'term': 'benoxinate'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients, the surgeons and the research team will be blinded to the randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-25', 'studyFirstSubmitDate': '2018-11-04', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sedation score changes', 'timeFrame': 'baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours', 'description': 'Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.'}], 'secondaryOutcomes': [{'measure': 'pain score changes', 'timeFrame': 'baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours', 'description': 'verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor ≥ 3 indicates need of analgesia'}, {'measure': 'heart rate changes', 'timeFrame': 'baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours', 'description': 'beats/minute'}, {'measure': 'arterial blood pressure changes', 'timeFrame': 'baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours', 'description': 'mmHg'}, {'measure': 'arterial oxygen saturation', 'timeFrame': 'baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours', 'description': 'the percentage of hemoglobin saturation with oxygen in arterial blood.'}, {'measure': 'respiratory rate', 'timeFrame': 'baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours', 'description': 'breath/minute'}, {'measure': 'total dexmedetomidine consumption', 'timeFrame': 'intraoperatively', 'description': 'ug'}, {'measure': 'Incidence of respiratory depression', 'timeFrame': 'from administering premedication till 24 hours postoperative.', 'description': 'percentage'}, {'measure': 'Incidence of hypotension', 'timeFrame': 'from administering premedication till 24hours postoperative', 'description': 'percentage'}, {'measure': 'Incidence of bradycardia', 'timeFrame': 'from administering premedication till 24hours postoperative', 'description': 'percentage'}, {'measure': 'Incidence of ataxia', 'timeFrame': 'from administering premedication till 24hours postoperative', 'description': 'percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Conscious Sedation']}, 'descriptionModule': {'briefSummary': 'Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.', 'detailedDescription': 'The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society Of Anesthesiologists (ASA) I and II physical status.\n* Scheduled for cataract extraction under topical anesthesia.\n\nExclusion Criteria:\n\n* Hepatic or renal impairment.\n* Taking chronic psychotropic medications.\n* Mental instability.\n* Morbid obesity.\n* Alcohol abuse.\n* Substance abuse.\n* Pregnant and lactating females.\n* History of allergy to the study drugs used'}, 'identificationModule': {'nctId': 'NCT03735368', 'briefTitle': 'Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': '2018/10/15/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'placebo oral capsule+ dexmedetomidine+topical anesthesia', 'interventionNames': ['Drug: Dexmedetomidine Injection', 'Drug: Placebo oral capsule', 'Drug: topical anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine- Pregabalin', 'description': 'Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia', 'interventionNames': ['Drug: Dexmedetomidine Injection', 'Drug: Pregabalin Oral Capsule', 'Drug: topical anesthesia']}], 'interventions': [{'name': 'Dexmedetomidine Injection', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine'], 'description': 'Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion', 'armGroupLabels': ['Control', 'Dexmedetomidine- Pregabalin']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'placebo oral capsules', 'armGroupLabels': ['Control']}, {'name': 'Pregabalin Oral Capsule', 'type': 'DRUG', 'otherNames': ['pregabalin'], 'description': '150 mg pregabalin Oral Capsule', 'armGroupLabels': ['Dexmedetomidine- Pregabalin']}, {'name': 'topical anesthesia', 'type': 'DRUG', 'otherNames': ['Benoxinate Hydrochloride 0.4% Eye Drops'], 'description': 'topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops', 'armGroupLabels': ['Control', 'Dexmedetomidine- Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Cairo', 'state': 'Shebin El-kom', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Abd-Elazeem A Elbakry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abd-Elazeem Abd-Elhameed Elbakry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Abd-Elazeem Abd-Elhameed Elbakry', 'investigatorAffiliation': 'Menoufia University'}}}}