[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659257":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":49,"overallOfficials":54,"centralContacts":59,"locations":68,"responsibleParty":84,"collaborators":37,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":37,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":100,"studyType":101,"phases":37,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":112,"whyStopped":37,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Sakarya University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Composite Intubation Condition Score","Composite intubation condition score (range 0-6; higher scores indicate better conditions): the sum of the three Good Clinical Research Practice (GCRP) 2023 components (ease of laryngoscopy, vocal cord position, reaction to intubation), each scored excellent 2, good 1, or poor 0, graded by the intubating anesthesiologist blinded to the Patient State Index (PSI). Analyzed as the odds ratio (95% CI) per 10-unit increase in PSI at laryngoscopy, from a proportional odds ordinal logistic regression adjusted for predicted propofol effect-site concentration, interval from neuromuscular blocking agent to laryngoscopy, and age.","At laryngoscopy (T2), typically within 10 minutes of the start of induction of anesthesia",[14,18,22,26,30,33],{"measure":15,"description":16,"timeFrame":17},"Patient State Index in clinically acceptable versus unacceptable intubation conditions","Median PSI at laryngoscopy in participants with clinically acceptable (excellent or good) and unacceptable (poor) overall intubation conditions, with the Hodges-Lehmann median difference and its 95% confidence interval; and the adjusted odds ratio per 10-unit increase in PSI from a binary logistic regression with the same three confounders as the primary model. If fewer than 5 participants have unacceptable conditions, results are reported descriptively only and no model is fitted.","At laryngoscopy (T2)",{"measure":19,"description":20,"timeFrame":21},"Percentage Change in Mean Arterial Pressure at 1 Minute After Intubation","Percentage change in mean arterial pressure (MAP) from baseline to 1 minute after intubation, \\[(MAP at T3 - MAP at T0) \u002F MAP at T0\\] x 100, measured non-invasively. Analyzed as the regression coefficient (95% CI) per 10-unit increase in the Patient State Index (PSI) at laryngoscopy, from a multiple linear regression adjusted for the same three confounders as the primary outcome. A positive coefficient is expected, since a higher PSI indicates lighter hypnosis. A sensitivity analysis excludes participants who received remifentanil, a vasoactive drug or an additional anesthetic before T3.","Baseline (T0), laryngoscopy (T2), and 1 minute after completion of intubation (T3)",{"measure":23,"description":24,"timeFrame":25},"Percentage Change in Mean Arterial Pressure at 3 Minutes After Intubation","Percentage change in mean arterial pressure (MAP) from baseline to 3 minutes after intubation, \\[(MAP at T4 - MAP at T0) \u002F MAP at T0\\] x 100, measured non-invasively. Analyzed as the regression coefficient (95% CI) per 10-unit increase in the Patient State Index (PSI) at laryngoscopy, from a multiple linear regression adjusted for the same three confounders as the primary outcome. A positive coefficient is expected, since a higher PSI indicates lighter hypnosis. A sensitivity analysis excludes participants who received remifentanil, a vasoactive drug or an additional anesthetic before T4.","Baseline (T0), laryngoscopy (T2), and 3 minutes after completion of intubation (T4)",{"measure":27,"description":28,"timeFrame":29},"Change in Patient State Index From Neuromuscular Blocking Agent Administration to Laryngoscopy","Within-participant change in the Patient State Index (PSI; SedLine processed-EEG index, range 0-100; lower values indicate deeper hypnosis) from administration of the neuromuscular blocking agent (T1) to laryngoscopy (T2), tested with the Wilcoxon signed-rank test. Descriptive only: there is no comparison group without neuromuscular blockade, and the propofol infusion is stopped at T1 so its effect-site concentration changes over the same interval; the change therefore cannot be attributed to electromyographic suppression.","Administration of the neuromuscular blocking agent (T1) to laryngoscopy (T2), up to 15 minutes",{"measure":31,"description":32,"timeFrame":29},"Change in SedLine Electromyography (EMG) Index From Neuromuscular Blocking Agent Administration to Laryngoscopy","Within-participant change in the SedLine electromyography (EMG) index (range 0-100%; higher values indicate more facial muscle activity) from administration of the neuromuscular blocking agent (T1) to laryngoscopy (T2), tested with the Wilcoxon signed-rank test. Descriptive only: there is no comparison group without neuromuscular blockade.",{"measure":34,"description":35,"timeFrame":36},"Number of Participants With Sore Throat or Hoarseness on the First Postoperative Day","Number (%) of participants with sore throat or hoarseness (either symptom) on structured inquiry on the first postoperative day. Analyzed as the odds ratio (95% CI) per 1-point increase in the composite intubation condition score (range 0-6; higher scores indicate better conditions), from a logistic regression.","First postoperative day (approximately 24 hours after surgery)",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","PROSPECTIVE","Background. Inadequate hypnotic depth at laryngoscopy may provoke laryngeal reflexes, hemodynamic responses and airway trauma. The 2023 Good Clinical Research Practice (GCRP) guideline recommends that depth of anesthesia at intubation be measured objectively. Previous studies used the bispectral index; the Patient State Index (PSI) has not been studied, and the two indices are not interchangeable.\n\nDesign. Single-center, prospective, observational cohort study of consecutive eligible patients in one operating room, where all intubations are performed by the same attending anesthesiologist. Processed-EEG (SedLine) and quantitative neuromuscular monitoring are part of routine care; no additional monitoring is applied.\n\nRoutine practice (not mandated by the protocol). Lidocaine 1 mg\u002Fkg and fentanyl 1 µg\u002Fkg, then propofol target-controlled infusion (Eleveld model, effect-site target 3 µg\u002FmL). When the target is reached, the infusion is stopped and rocuronium 0.6 mg\u002Fkg is given; the trachea is intubated by direct laryngoscopy when the train-of-four count reaches zero. The protocol prescribes no drug, dose or timing; the drugs actually given and any deviation are recorded.\n\nBlinding and safety. From induction until intubation conditions have been graded, the SedLine display is turned away from the intubating anesthesiologist. This does not alter care, because the timing of intubation is routinely based on the effect-site target and the train-of-four count, both of which remain visible. An independent observer records the EEG variables, watches the display, and immediately informs the anesthesiologist if PSI exceeds 60 for more than 30 seconds after the neuromuscular blocking agent; all clinical decisions remain with the anesthesiologist. Awareness is assessed on the first postoperative day with a modified Brice questionnaire.\n\nMeasurements. T0 = baseline; T1 = neuromuscular blocking agent; T2 = laryngoscope insertion; T3 and T4 = 1 and 3 minutes after intubation. Because the SedLine displays PSI with a delay of about 25 seconds, the PSI at each time point is the median of trend values from 5 seconds before to 25 seconds after the event, which reflects the 30 seconds of EEG preceding it. Participants with a median artifact percentage above 10% in the T2 window are flagged. The intubating anesthesiologist grades the three GCRP\u002FCopenhagen components (ease of laryngoscopy, vocal cord position, reaction to intubation; excellent = 2, good = 1, poor = 0), which are summed into a composite score of 0 to 6; the standard categorical grade is also reported. The independent observer grades the reaction component a second time to assess inter-observer agreement.\n\nAnalysis. Proportional odds ordinal logistic regression of the composite score on the PSI at laryngoscopy, adjusted for three pre-specified confounders: predicted propofol effect-site concentration at laryngoscopy, interval from neuromuscular blocking agent to laryngoscopy, and age. The effect measure is the odds ratio per 10-unit increase in PSI with its 95% confidence interval. The question is whether the PSI adds information beyond what the anesthesiologist already knows; the model is associational, not causal. Pre-specified sensitivity analyses exclude, in turn, participants with Cormack-Lehane grade 3-4, a failed first attempt, a safety alert, an additional dose of neuromuscular blocking agent, a train-of-four count above zero, or artifact above 10%. Secondary outcomes are exploratory. Model checks and fallback models are specified in the statistical analysis plan.\n\nSample size. Power was estimated by simulation for the proportional odds model, allowing for the expected ceiling effect in the composite score and for correlation between the PSI and the confounders. To detect an odds ratio of 0.50 per 10 PSI units with 80% power (two-sided alpha 0.05), under the conservative assumption that 75% of participants reach the maximum score, 145 analyzable participants are required; allowing for 10% loss, 162 participants will be enrolled.","Consecutive adult women scheduled for elective surgery under general anesthesia with orotracheal intubation in the study operating room of a single tertiary training and research hospital.",[44],{"label":45,"type":37,"description":46,"interventionNames":47},"Adult women undergoing elective general anesthesia with orotracheal intubation","Single cohort. All participants receive routine anesthetic care determined by the attending anesthesiologist, including routine processed-EEG and quantitative neuromuscular monitoring. No group assignment or treatment is made by the protocol.",[48],"Other: Depth of anesthesia at laryngoscopy (Patient State Index)",[50],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"Depth of anesthesia at laryngoscopy (Patient State Index)","Exposure of interest, not an assigned intervention. The Patient State Index is measured with routinely used SedLine processed-EEG monitoring at the moment of laryngoscopy. The display is kept out of view of the intubating anesthesiologist until intubation conditions have been graded. No aspect of anesthetic management is directed by the protocol.",[45],[55],{"name":56,"affiliation":57,"role":58},"Ayca Tas Tuna, Professor, M.D.","Sakarya University Faculty of Medicine","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":37,"email":64},"AHMET R DOĞAN","CONTACT","+905427988070","a.ridvandogan@gmail.com",{"name":66,"role":62,"phone":37,"phoneExt":37,"email":67},"Ayça Taş Tuna, Prof. Dr","aycatas@yahoo.com",[69],{"facility":70,"status":37,"city":71,"state":72,"zip":73,"country":74,"countryCode":37,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation","Sakarya","Adapazari","54000","Turkey (Türkiye)",{"type":76,"coordinates":77},"Point",[78,79],32.07583,39.50333,{"lat":79,"lon":78},[82],{"name":83,"role":62,"phone":63,"phoneExt":37,"email":64},"Ahmet R Doğan",{"type":58,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Ayça Taş Tuna","Prof.Dr.","100659257","patient-state-index-at-laryngoscopy-and-tracheal-intubation-conditions-100659257",false,"NCT07864402","Patient State Index at Laryngoscopy and Tracheal Intubation Conditions","Association Between Depth of Hypnosis Measured by the Patient State Index at Laryngoscopy and the Quality of Tracheal Intubation Conditions: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* \\- Female sex\n* \\- Age 18 to 65 years\n* \\- ASA physical status I to III\n* \\- Scheduled for elective surgery under general anesthesia with planned orotracheal intubation\n* \\- Written informed consent\n\nExclusion Criteria:\n\n* \\- Anticipated difficult intubation (Mallampati class III or IV, thyromental distance less than 6 cm, or a history of difficult intubation)\n* \\- Neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, muscular dystrophy)\n* \\- Chronic opioid use for more than 4 weeks\n* \\- Body mass index greater than 35 kg\u002Fm²\n* \\- Known allergy or hypersensitivity to the anesthetic agents to be used\n* \\- Chronic use of antidepressant, antipsychotic or antiepileptic medication for\n* a neurological or psychiatric disorder\n* \\- Severe cardiovascular disease (ejection fraction below 40%, uncontrolled hypertension, or unstable angina)\n* \\- Hepatic failure (Child-Pugh class B or C)\n* \\- Indication for rapid sequence induction\n* \\- Any condition preventing application of a frontal EEG sensor","FEMALE","18 Years","65 Years",{"count":98,"type":99},162,"ESTIMATED","1 Day","OBSERVATIONAL","The goal of this observational study is to learn whether the depth of anesthesia at the moment the breathing tube is placed is related to how easily the tube can be placed, in adult women (18 to 65 years) having planned surgery under general anesthesia. Depth of anesthesia is measured with the Patient State Index (PSI), a number from 0 to 100 shown by a brain-activity monitor (SedLine) with a sensor placed on the forehead; lower numbers mean deeper anesthesia.\n\nThe main questions it aims to answer are:\n\n* Is the PSI at the moment of tube placement related to the quality of intubation conditions: how relaxed the jaw is, how open the vocal cords are, and whether the patient coughs or moves?\n* Does the PSI tell the anesthesia team something about these conditions beyond what they already know from the anesthetic dose, the timing of the muscle relaxant, and the patient's age?\n\nThere is no comparison group; all participants are in one group.\n\nParticipants will:\n\n* Receive their usual anesthesia care. The study does not change any drug, dose or timing, and all decisions stay with their anesthesiologist.\n* Have their depth of anesthesia and muscle relaxation recorded with monitors that are already part of routine care at this hospital. While the breathing tube is being placed, the brain-activity monitor screen is turned away from the anesthesiologist placing the tube, and a second doctor watches it the whole time.\n* Answer a few short questions on the day after surgery about sore throat, hoarseness, and whether they remember anything from the operation.",[104,105,106],"Anesthesia","Intubation, Endotracheal","Anesthesia Depth Monitoring",[108,109,110,111],"patient state index","depth of anesthesia","intubation conditions","copenhagen score","NOT_YET_RECRUITING","2026-10-02",{"date":115,"type":116},"2026-10-07","ACTUAL",{"date":118,"type":99},"2026-10-01",{"date":120,"type":99},"2027-10-01",{"name":5,"class":6},1]