Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorSakarya University
About this trial
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
This trial does not accept healthy volunteersQualifiers
- Female sex
- Age 18 to 65 years
- ASA physical status I to III
- Scheduled for elective surgery under general anesthesia with planned orotracheal intubation
Disqualifiers
- 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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Depth of anesthesia at laryngoscopy (Patient State Index)
Other interventionExposure 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.
Treatment groups
162 Participants
are divided into 1 treatment groupGroup A: Adult women undergoing elective general anesthesia with orotracheal intubation1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At laryngoscopy (T2), typically within 10 minutes of the start of induction of anesthesiaSecondary outcomes
1
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.
Time frame
At laryngoscopy (T2)2
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, \[(MAP at T3 - MAP at T0) / MAP at T0\] 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.
Time frame
Baseline (T0), laryngoscopy (T2), and 1 minute after completion of intubation (T3)3
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, \[(MAP at T4 - MAP at T0) / MAP at T0\] 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.
Time frame
Baseline (T0), laryngoscopy (T2), and 3 minutes after completion of intubation (T4)4
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.
Time frame
Administration of the neuromuscular blocking agent (T1) to laryngoscopy (T2), up to 15 minutesSponsors and contacts
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Source ClinicalTrials.gov
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