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Not Yet Recruiting NCT07864402

Patient State Index at Laryngoscopy and Tracheal Intubation Conditions

Conditions: Anesthesia, Intubation, Endotracheal, Anesthesia Depth Monitoring

Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 162
Sponsor: Sakarya University

Location: Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation Sakarya Adapazari

Summary

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. The main questions it aims to answer are: * 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? * 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? There is no comparison group; all participants are in one group. Participants will: * Receive their usual anesthesia care. The study does not change any drug, dose or timing, and all decisions stay with their anesthesiologist. * 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. * Answer a few short questions on the day after surgery about sore throat, hoarseness, and whether they remember anything from the operation.

Eligibility Criteria

Inclusion Criteria: * \- Female sex * \- Age 18 to 65 years * \- ASA physical status I to III * \- Scheduled for elective surgery under general anesthesia with planned orotracheal intubation * \- Written informed consent Exclusion Criteria: * \- Anticipated difficult intubation (Mallampati class III or IV, thyromental distance less than 6 cm, or a history of difficult intubation) * \- Neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, muscular dystrophy) * \- Chronic opioid use for more than 4 weeks * \- Body mass index greater than 35 kg/m² * \- Known allergy or hypersensitivity to the anesthetic agents to be used * \- Chronic use of antidepressant, antipsychotic or antiepileptic medication for * a neurological or psychiatric disorder * \- Severe cardiovascular disease (ejection fraction below 40%, uncontrolled hypertension, or unstable angina) * \- Hepatic failure (Child-Pugh class B or C) * \- Indication for rapid sequence induction * \- Any condition preventing application of a frontal EEG sensor

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07864402). StuddyBuddy aggregates publicly available trial information.