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NOT YET RECRUITING
NCT07864402

Patient State Index at Laryngoscopy and Tracheal Intubation Conditions

Sponsor: Sakarya University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

162

Start Date

2026-10-01

Completion Date

2027-10-01

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation

Sakarya, Adapazari, Turkey (Türkiye)