[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655821":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":53,"studyPopulation":54,"armGroups":55,"interventions":66,"overallOfficials":49,"centralContacts":49,"locations":79,"responsibleParty":102,"collaborators":49,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":49,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":49,"enrollmentInfo":113,"targetDuration":49,"studyType":116,"phases":49,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":82,"whyStopped":49,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":49},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Total Intraoperative Remifentanil Consumption","Total amount of intravenous remifentanil administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the remifentanil-only group and the remifentanil plus subcostal TAP block group.","From induction of general anesthesia until the end of surgery",{"measure":14,"description":15,"timeFrame":12},"Intraoperative Bispectral Index Values","Bispectral Index (BIS) values recorded during general anesthesia will be evaluated to assess anesthetic depth and compared between the two observational groups.",{"measure":17,"description":18,"timeFrame":12},"Intraoperative EEG Alpha-Band Activity","Changes in electroencephalographic alpha-band activity during general anesthesia and surgical stimulation will be recorded and compared between the two observational groups.",{"measure":20,"description":21,"timeFrame":12},"Intraoperative Burst Suppression","Burst suppression observed on intraoperative EEG monitoring during general anesthesia will be recorded and compared between the two observational groups.",[23,26,30,33,37,41,45],{"measure":24,"description":25,"timeFrame":12},"Total Intraoperative Fentanyl Consumption","The total dose of intravenous fentanyl administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the two observational groups.",{"measure":27,"description":28,"timeFrame":29},"Postoperative Pain at Rest","Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.","At 0, 1, 4, 8, 12, and 24 hours after surgery",{"measure":31,"description":32,"timeFrame":29},"Postoperative Pain During Activity","Pain intensity during activity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.",{"measure":34,"description":35,"timeFrame":36},"Total Postoperative Rescue Tramadol Consumption","The total dose of intravenous tramadol administered as rescue analgesia for postoperative pain with an NRS score of 4 or greater will be recorded.","During the first 24 hours after surgery",{"measure":38,"description":39,"timeFrame":40},"Quality of Recovery-15 Score","Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.","At 24 hours after surgery",{"measure":42,"description":43,"timeFrame":44},"Time to First Mobilization","The time from completion of surgery to the patient's first postoperative mobilization will be recorded.","Up to 24 hours after surgery",{"measure":46,"description":47,"timeFrame":48},"Length of Hospital Stay","The duration of postoperative hospital stay will be recorded and compared between the two observational groups.","From completion of surgery until hospital discharge Up to 7 days",null,{"allocation":49,"interventionModel":49,"interventionModelDescription":49,"primaryPurpose":49,"observationalModel":51,"timePerspective":52,"maskingInfo":49},"COHORT","PROSPECTIVE","This is a prospective, single-center observational study including adult patients scheduled for laparoscopic cholecystectomy under general anesthesia. The study will be conducted at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital.\n\nPerioperative analgesic management will be determined by the attending anesthesiologist according to routine clinical practice and will not be assigned by the study protocol. Patients will subsequently be evaluated in two observational groups according to the analgesic technique received. One group will consist of patients receiving intravenous remifentanil infusion without a subcostal TAP block, while the other group will consist of patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal TAP block.\n\nGeneral anesthesia will be maintained using sevoflurane and remifentanil according to routine clinical practice. Depth of anesthesia and cerebral electrical activity will be monitored using Bispectral Index (BIS) monitoring and electroencephalography (EEG). Intraoperative EEG characteristics, including changes in alpha-band activity and burst suppression, as well as BIS values, will be recorded and compared between the two groups.\n\nIntraoperative analgesic consumption, including remifentanil and additional fentanyl use, will be recorded from anesthesia records. Hemodynamic responses and other routinely monitored parameters will also be documented.\n\nPostoperative pain will be evaluated using the Numerical Rating Scale (NRS) at rest and during activity at 0, 1, 4, 8, 12, and 24 hours after surgery. Routine postoperative analgesia includes intravenous paracetamol and tenoxicam. When clinically indicated for inadequate pain control, rescue analgesia with intravenous tramadol may be administered according to routine clinical practice, and additional analgesic consumption will be recorded.\n\nPostoperative recovery will additionally be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Mobilization time, length of hospital stay, and patient satisfaction will also be recorded.\n\nThe primary objective of the study is to evaluate the association between subcostal TAP block use and intraoperative analgesic requirements, anesthetic depth, EEG dynamics, and burst suppression. Secondary objectives include comparison of postoperative pain, additional analgesic consumption, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction between the two groups.","Adult patients aged 18 years or older with ASA physical status I-III who are scheduled to undergo laparoscopic cholecystectomy under general anesthesia at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital and who provide written informed consent will be included. Patients will be evaluated according to the perioperative analgesic technique selected by the attending anesthesiologist as part of routine clinical care.",[56,61],{"label":57,"type":49,"description":58,"interventionNames":59},"Remifentanil Group","Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.",[60],"Drug: Remifentanil",{"label":62,"type":49,"description":63,"interventionNames":64},"Remifentanil + Subcostal TAP Block Group","Patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal transversus abdominis plane (TAP) block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.",[60,65],"Procedure: Ultrasound-Guided Subcostal Transversus Abdominis Plane Block",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":49},"DRUG","Remifentanil","Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.",[62,57],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"PROCEDURE","Ultrasound-Guided Subcostal Transversus Abdominis Plane Block","Ultrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision.",[62],[78],"subcostal TAP Block",[80],{"facility":81,"status":82,"city":83,"state":49,"zip":49,"country":84,"countryCode":49,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital","RECRUITING","Istanbul","Turkey (Türkiye)",{"type":86,"coordinates":87},"Point",[88,89],28.94966,41.01384,{"lat":89,"lon":88},[92,97,99],{"name":93,"role":94,"phone":95,"phoneExt":49,"email":96},"Department of Anesthesiology and Reanimation, MD","CONTACT","+90 216 606 33 00","sancaktepeetikkurul@gmail.com",{"name":98,"role":94,"phone":49,"phoneExt":49,"email":49},"Ezgi Erdag, MD",{"name":100,"role":101,"phone":49,"phoneExt":49,"email":49},"Nurten Bakan","PRINCIPAL_INVESTIGATOR",{"type":103,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100655821","subcostal-tap-block-and-eeg-dynamics-in-laparoscopic-cholecystectomy-100655821",false,"NCT07818954","Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy","Effect of Subcostal Transversus Abdominis Plane Block on Analgesia, EEG Dynamics, and Burst Suppression in Laparoscopic Cholecystectomy","Inclusion Criteria:\n\n* Age 18 years or older\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Scheduled to undergo laparoscopic cholecystectomy under general anesthesia\n* Written informed consent provided by the participant or, when applicable, the legally authorized representative\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* American Society of Anesthesiologists (ASA) physical status IV-V\n* Known allergy or hypersensitivity to medications used during perioperative anesthetic or analgesic management","ALL","18 Years",{"count":114,"type":115},60,"ESTIMATED","OBSERVATIONAL","Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure. Despite its minimally invasive nature, surgical stimulation and pneumoperitoneum may cause pain-related physiological and neurophysiological responses during general anesthesia.\n\nThis prospective observational study will evaluate patients undergoing laparoscopic cholecystectomy under general anesthesia. Patients will be observed according to the analgesic technique selected by the attending anesthesiologist as part of routine clinical care: intravenous remifentanil alone or remifentanil combined with an ultrasound-guided subcostal transversus abdominis plane (TAP) block.\n\nThe study will examine the relationship between the use of subcostal TAP block and intraoperative analgesic requirements, Bispectral Index (BIS) values, electroencephalographic (EEG) dynamics, and burst suppression. Postoperative pain scores, additional analgesic requirements, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction will also be evaluated.",[119,120,121],"Laparoscopic Cholecystectomy","Postoperative Pain","Intraoperative Nociception",[123,124,125,126,127,128,129,130,131,69,132,133],"Subcostal TAP Block","Transversus Abdominis Plane Block","Electroencephalography","EEG","Bispectral Index","BIS","Burst Suppression","Intraoperative Analgesia","Multimodal Analgesia","Nociception","Quality of Recovery","2026-09-11",{"date":136,"type":137},"2026-09-14","ACTUAL",{"date":139,"type":137},"2026-07-15",{"date":141,"type":115},"2026-12-31",{"name":5,"class":6},1]