Loading search results
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
Sponsor study identifier
observational
162
1 country
1
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 23, 2026
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 7, 2026
Actual (reported)April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Patient State Index in clinically acceptable versus unacceptable intubation conditions
At laryngoscopy (T2)
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
Sakarya, Adapazari, 54000, Turkey (Türkiye)
Ayca Tas Tuna, Professor, M.D.
Sakarya University Faculty of Medicine
First Submitted
September 23, 2026
First Posted
October 7, 2026
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Percentage Change in Mean Arterial Pressure at 1 Minute After Intubation
Baseline (T0), laryngoscopy (T2), and 1 minute after completion of intubation (T3)
Percentage Change in Mean Arterial Pressure at 3 Minutes After Intubation
Baseline (T0), laryngoscopy (T2), and 3 minutes after completion of intubation (T4)
Change in Patient State Index From Neuromuscular Blocking Agent Administration to Laryngoscopy
Administration of the neuromuscular blocking agent (T1) to laryngoscopy (T2), up to 15 minutes
Change in SedLine Electromyography (EMG) Index From Neuromuscular Blocking Agent Administration to Laryngoscopy
Administration of the neuromuscular blocking agent (T1) to laryngoscopy (T2), up to 15 minutes
Contact the study team to confirm eligibility.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request to the corresponding author, subject to approval of a methodologically sound proposal and a data sharing agreement.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: