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Trial · NCT07035301

Registered outcomes40

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe incidence rate of laryngeal spasmFrom initiation of anesthesia induction to completion of bronchoscope insertion
Observe the degree of glottic opening (grade I: glottis opens well; grade II: glottis opens \>⅔, mild laryngospasm; grade III: glottis opens ⅓-⅔, moderate laryngospasm; grade IV: glottis opens ≤⅓ or is completely closed, severe laryngospasm).Grades III and IV were defined as laryngospasm.
SecondaryThe severity of postoperative sore throatWhen the patient regained consciousness (assessed up to 30 minutes after surgery)
The patient's sore throat was evaluated using the visual analogue scale. A 10-cm movable ruler with 10 marks was used, with the two ends marked at 0 and 10 respectively. The patient was asked to mark the corresponding position on the ruler that represented their degree of pain. 0 represented no pain, and 10 represented extremely painful.
SecondaryDysphagiaWhen the patient regained consciousness (assessed up to 30 minutes after surgery)After the surgery, inquire whether the patient has any difficulty in swallowing.
SecondaryThe incidence of oxygen desaturation (SpO₂ < 92%) during mask ventilationduring anesthesia inductionThe number of patients with SpO₂ \< 92% during mask ventilation in the induction period / total number of patients in the group
SecondaryGrading of body movement during bronchoscope insertionAt the beginning of the operation
Grade 1: Slight movement that does not interfere with the procedure. Grade 2: Pronounced movement that interferes with the procedure. Grade 3: Thrashing or vigorous movement that significantly interferes with the procedure.
SecondaryGrading of chest wall rigidityDuring the process of anesthesia induction
Mild: No difficult ventilation but with stiffness of the limbs or abdominal wall. Moderate: Difficult ventilation accompanied by noticeable limb stiffness or abdominal wall rigidity. Severe: Inability to ventilate with significant limb stiffness or abdominal wall rigidity.
SecondaryDifficult facemask ventilationDuring the process of anesthesia induction
Grade A represented the presence of an end-tidal carbon dioxide (PETCO₂) waveform plateau; Grade B, the absence of a plateau but with a PETCO₂ value ≥ 10 mmHg; Grade C, the absence of a plateau and a PETCO₂ value \< 10 mmHg; and Grade D, the absence of a detectable PETCO₂ waveform. Grades C and D were classified as difficult facemask ventilation.
SecondaryThe incidence rate of choking cough when the bronchoscope first enters the tracheaAt the beginning of the operationGrade 0: no choking cough response; grade 1: single mild choking cough response; grade 2: multiple mild choking cough responses(\<=5s); grade 3: severe choking cough response(\>5s).
SecondaryNauseaWhen the patient regained consciousness (assessed up to 30 minutes after surgery)After the surgery, ask the patient if they are experiencing nausea.
SecondaryNumber of laryngeal mask placementsDuring the process of anesthesia inductionRecord the number of times the laryngeal mask is inserted when it is placed.
SecondaryVomitWhen the patient regained consciousness (assessed up to 30 minutes after surgery)After the surgery, ask the patient if they feel like vomiting.
SecondaryIs it easy to insert the laryngeal mask?During the process of anesthesia induction
The difficulty level of inserting the laryngeal mask can be determined by observing the mouth opening during insertion, the resistance encountered during insertion, the presence or absence of choking and body movement, and the time taken for insertion. It is classified into four levels: simple, slightly difficult, difficult, and failed.
SecondaryBloating of stomachWhen the patient regained consciousness (assessed up to 30 minutes after surgery)After the patient regains consciousness, ask the patient if they have any bloating in the stomach.
SecondaryhoarsenessWhen the patient regained consciousness (assessed up to 30 minutes after surgery)After the patient regains consciousness, the presence of hoarseness in the patient is determined through communication with the patient.
SecondaryTime of laryngeal mask placementDuring the process of anesthesia induction
The time required for laryngeal mask airway (LMA) insertion was measured from the initiation of the insertion attempt until correct placement was confirmed by the appearance of a normal end-tidal carbon dioxide (ETCO₂) waveform on capnography.
Secondaryblood pressureThe time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours)
Blood Pressure: The lateral pressure exerted by blood on the walls of blood vessels when it flows within them. Systolic blood pressure (SBP): The highest pressure in the arteries during the contraction of the heart (normal range: 90 - 120 mmHg). Diastolic blood pressure (DBP): The lowest pressure in the arteries during the relaxation of the heart (normal range: 60 - 80 mmHg).
Secondaryheart rateThe time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours)
Heart Rate: Number of heartbeats per minute (unit: beats per minute, bpm). . Normal resting heart rate: 60-100 beats per minute for adults. (For athletes or those who engage in long-term exercise, it can be as low as 40-50 beats per minute.)
Secondaryoxyhemoglobin saturationThe time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours)
Blood oxygen saturation (SpO2): The percentage of oxyhemoglobin (HbO2) in the blood relative to the total hemoglobin (Hb), reflecting the oxygenation status of the body. . Normal range: For healthy adults at rest, it is 95% - 100%. Anything below 90% indicates hypoxemia.
SecondaryBispectral indexThe time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours)
BIS is a method that analyzes the linear (frequency, power) and non-linear (phase, harmonic) components of electroencephalogram (EEG) data, converting them into quantitative indicators ranging from 0 to 100, which is used to assess the inhibitory or excitatory state of the cerebral cortex. Value range: 0 indicates no brainwave activity, and 100 represents a fully awake state. Core function: Primarily used for monitoring the depth of anesthesia, the level of sedation, and the state of consciousness, reducing the risk of intraoperative awareness.
Secondaryairway peak pressureThe period from the start of anesthesia induction to the time when the patient leaves the operating room after the surgery is completed (up to 4 hours)
Airway peak pressure is a very important parameter in mechanical ventilation, referring to the highest pressure value reached within one inhalation phase in the breathing circuit. The normal range is typically between 15 - 30 cmH2O. However, this varies depending on factors such as the patient's pathophysiological condition, ventilation mode, tidal volume, flow rate, and PEEP setting.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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