Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-07 @ 6:52 AM
Study NCT ID:
NCT06412861
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2024-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to one of two groups (1:1 ratio, parallel randomization) by randomization using the computer program "ResearchRandomizer" (Urbaniak and Plous 2013), conducted by a team member not involved in surgery or patient assessment. There will be 30 patients in each group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-18', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical satisfaction', 'timeFrame': 'Postoperative procedure', 'description': 'Surgical satisfaction survey:\n\nWas the level of sedation sufficient during local anesthesia administration? Was the level of sedation sufficient throughout the surgical procedure? Was your verbal communication level with the patient sufficient? Would you recommend this sedation method to other surgeons for this surgical procedure? Would you accept using the same sedation technique for your next surgical procedure with the patient? Scoring: Ratings are based on a scale of 0 to 2, where 0 indicates \'not at all\', 1 indicates \'somewhat\', and 2 indicates \'completely\'. The scores are evaluated on a scale from the lowest \'0\' to the highest \'10\'."'}, {'measure': 'Incidence of lower extremity movement during the procedure', 'timeFrame': 'intraoperative', 'description': 'The incidence of lower extremity movement indicative of inadequate sedation or analgesia during the procedure'}], 'secondaryOutcomes': [{'measure': 'Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia)', 'timeFrame': '30th minute postoperative', 'description': 'he side effects occurring during the intraoperative and postoperative periods include:\n\nRecall events (recall of events during surgery) Apnea (holding breath for \\>15 seconds) Desaturation (SpO2 \\< 96%) Jaw thrust maneuver Bradycardia (heart rate \\< 50 beats/min) Skin rash'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ketamine', 'sedation', 'gynecological case'], 'conditions': ['Ketamine', 'Sedation', 'Gynecologic Disease']}, 'referencesModule': {'references': [{'pmid': '9356094', 'type': 'BACKGROUND', 'citation': 'Sa Rego MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. doi: 10.1097/00000539-199711000-00012. No abstract available.'}, {'pmid': '10735789', 'type': 'BACKGROUND', 'citation': 'Badrinath S, Avramov MN, Shadrick M, Witt TR, Ivankovich AD. The use of a ketamine-propofol combination during monitored anesthesia care. Anesth Analg. 2000 Apr;90(4):858-62. doi: 10.1097/00000539-200004000-00016.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases\n\nOur study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort.', 'detailedDescription': "Procedural sedation is widely used in various medical procedures worldwide, aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patient's cardiorespiratory function during painful or unpleasant interventions (1,2). Many drugs are used alone or in combination for this purpose (e.g., benzodiazepines, opioids such as fentanyl and remifentanil, midazolam, ketamine, propofol, dexmedetomidine) (6). This prospective, randomized, double-blind study will evaluate the effectiveness of ketamine-propofol and fentanyl-propofol combinations during short-term gynecological procedures by comparing the frequency of lower extremity movements in sedated patients.\n\nParticipants eligible for the study will include individuals aged 18-65 with American Society of Anesthesiologists (ASA) physical status I or II undergoing short gynecological procedures lasting less than 30 minutes. Participants with allergies to study medications, obesity, or behavioral disorders will be excluded. All participants will provide written informed consent the day before the procedure.\n\nEnrolled participants will be divided into two groups: Group K, receiving ketamine and propofol, and Group F, receiving fentanyl and propofol. Heart rate (HR), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), Ramsey Sedation Score( 1: Awake; agitated or restless or both, 2: Awake; cooperative, oriented, and tranquil,3: Awake but responds to commands only, 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus,5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, 6: Asleep; no response to glabellar tap or loud auditory stimulus)( RSS), and Facial Pain Score(0:No hurt- 10:Hurts worst (FPS) will be evaluated at five time points: T1 (pre-induction), T2 (1 minute post-induction), T3 (3 minutes post-induction), T4 (end of surgery), and T5 (30 minutes postoperatively).\n\n) In Group K, ketamine-propofol will be prepared in a 1:1 ratio (both 10 mg/mL) in the same syringe, while in Group F, fentanyl (1-2 mcg/kg) and propofol (1 mg/kg) will be prepared separately. Sedation will be initiated with 0.2 mL/kg of ketofol. Surgery will commence if RSS \\> 4; if the desired sedation level is not achieved, a rescue dose of 0.5 mg/kg propofol bolus will be administered."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18-65,\n* American Society of Anesthesiologists (ASA) I-II,\n\nExclusion Criteria:\n\n* Patients with a known allergy to any of the drugs used in the study,\n* Renal, hepatic, neuro-psychiatric, cardiovascular, or respiratory diseases, i\n* intracranial space-occupying lesions,\n* Pregnant women,\n* Body mass index (BMI) \\> 30'}, 'identificationModule': {'nctId': 'NCT06412861', 'briefTitle': 'Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases', 'orgStudyIdInfo': {'id': 'ilke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine-propofol', 'description': '0.5 mg/kg ketamine + 1 mg/kg propofol will be administered. Ramsey Sedation Score will be targeted to be \\> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl-propofol', 'description': '1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \\> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['GROUP A'], 'description': '0.5 mg/kg ketamine + 1 mg/kg propofol, Ramsey Sedation Score \\> 4 will be targeted. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.', 'armGroupLabels': ['ketamine-propofol']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['GROUP B'], 'description': '1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \\> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.', 'armGroupLabels': ['fentanyl-propofol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University Faculty of Medicine', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'ilke tamdoğan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ndokuz Mayıs University Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ilke Tamdogan', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}