The purpose of this clinical trial is to observe the use of low-dose muscle relaxants in bronchoscopy intervention surgeries, compared with no muscle relaxants, in terms of the satisfaction of tracheal tube insertion after anesthesia induction, the incidence of laryngospasm, the grading of intraoperative cough and movement, and the recovery of patients after surgery. The main questions it aims to answer are: * How safe and feasible is the use of low-dose muscle relaxants in bronchoscopy intervention surgeries? * Is the muscle relaxant regimen better than the no-muscle-relaxant regimen? Participants will: * During anesthesia induction, the experimental group will use low-dose muscle relaxants for anesthesia, while the control group will not use muscle relaxants for anesthesia. * Record the satisfaction of mask ventilation and the incidence of laryngospasm.
Objective: To investigate whether the prophylactic use of low-dose neuromuscular blocking agents, in addition to remimazolam combined with remifentanil for intravenous anesthesia, can reduce the incidence of difficult mask ventilation and laryngospasm during induction, and to systematically observe the effects of this regimen on intraoperative adverse reactions and the quality of postoperative recovery. Methods: A total of 154 patients undergoing elective bronchoscopic procedures were randomly divided into two groups: a muscle relaxant group (n=77) and a no-muscle relaxant group (n=77). Anesthesia induction in the muscle relaxant group was achieved with intravenous lidocaine 0.5 mg/kg, remimazolam 0.2 mg/kg, remifentanil 3 μg/kg, and rocuronium 0.15 mg/kg. The no-muscle relaxant group received the same regimen, except rocuronium was replaced with an equal volume of normal saline. A suitably sized laryngeal mask airway was inserted using a standard technique in both groups. Anesthesia was maintained with a continuous infusion of remimazolam at 1 mg/kg/h and remifentanil at 0.25-0.5 μg/kg/min. The primary outcome measures were the grade of chest wall rigidity, the incidence of difficult mask ventilation, the incidence of SpO₂ \<92% during mask ventilation, the incidence of laryngospasm, and the grade of coughing/body movement during bronchoscope insertion. Secondary outcome measures included the incidence of SpO₂ \<92% during bronchoscope insertion, perioperative changes in blood pressure, heart rate, oxygen saturation, bispectral index, airway pressure, and end-tidal carbon dioxide partial pressure; laryngeal mask airway insertion parameters (time, number of attempts, and ease of insertion); intraoperative drug dosages; the incidence of intraoperative and postoperative adverse reactions; and the quality of postoperative recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
During anesthesia induction, an equal volume of normal saline was used instead of rocuronium for anesthesia.
Lidocaine was administered at a dose of 0.5mg/kg for the induction of anesthesia.
Remimazolam was administered at a dose of 0.2 mg/kg for the induction of anesthesia.
Remifentanil was administered at a dose of 3 micrograms per kilogram for the induction of anesthesia.
Rocuronium was administered at a dose of 0.15mg/kg for the induction of anesthesia.
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The incidence rate of laryngeal spasm
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.
Time frame: At the beginning of the operation
The severity of postoperative sore throat
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.
Time frame: When the patient regained consciousness (assessed up to 30 minutes after surgery)
Dysphagia
After the surgery, inquire whether the patient has any difficulty in swallowing.
Time frame: When the patient regained consciousness (assessed up to 30 minutes after surgery)
The incidence of oxygen desaturation (SpO₂ < 92%) during mask ventilation
The number of patients with SpO₂ \< 92% during mask ventilation in the induction period / total number of patients in the group
Time frame: during anesthesia induction
Grading of body movement during bronchoscope insertion
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.
Time frame: At the beginning of the operation
Grading of chest wall rigidity
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.
Time frame: During the process of anesthesia induction
Difficult facemask ventilation
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.
Time frame: During the process of anesthesia induction
The incidence rate of choking cough when the bronchoscope first enters the trachea
Grade 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).
Time frame: At the beginning of the operation
Nausea
After the surgery, ask the patient if they are experiencing nausea.
Time frame: When the patient regained consciousness (assessed up to 30 minutes after surgery)
Number of laryngeal mask placements
Record the number of times the laryngeal mask is inserted when it is placed.
Time frame: During the process of anesthesia induction
Vomit
After the surgery, ask the patient if they feel like vomiting.
Time frame: When the patient regained consciousness (assessed up to 30 minutes after surgery)
Is it easy to insert the laryngeal mask?
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.
Time frame: During the process of anesthesia induction
Bloating of stomach
After the patient regains consciousness, ask the patient if they have any bloating in the stomach.
Time frame: When the patient regained consciousness (assessed up to 30 minutes after surgery)
hoarseness
After the patient regains consciousness, the presence of hoarseness in the patient is determined through communication with the patient.
Time frame: When the patient regained consciousness (assessed up to 30 minutes after surgery)
Time of laryngeal mask placement
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.
Time frame: During the process of anesthesia induction
blood pressure
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).
Time frame: The 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
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.)
Time frame: The time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours)
oxyhemoglobin saturation
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.
Time frame: The time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours)
Bispectral index
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.
Time frame: The time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours)
airway peak pressure
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.
Time frame: The 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 platform pressure
Airway plateau pressure is a key parameter for evaluating the pressure that alveoli can withstand in mechanical ventilation, reflecting the pressure (plus the set PEEP) required to overcome the elastic resistance (compliance) of the lungs and chest cavity. It can more directly reflect the degree of alveolar expansion at the end of inspiration and predict the risk of ventilator-associated lung injury (such as pressure injury, volume injury). The generally accepted safe upper limit is ≤ 30 cmH₂O (including PEEP).
Time frame: The 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)
Carbon dioxide at the end of breathing
End-tidal carbon dioxide (EtCO₂) monitoring is a non-invasive, real-time, and continuous important technique. By measuring the partial pressure (usually expressed in mmHg or kPa) or concentration (%) of carbon dioxide in the exhaled gas of the patient, it reflects the ventilation function, metabolic status, and circulatory status. It is an indispensable monitoring method in anesthesia, intensive care, emergency rescue (especially cardiopulmonary resuscitation). Normal value: Adult: 35 - 45 mmHg (approximately 4.7 - 6.0 kPa).
Time frame: The 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)
Dosage of Anesthetic Drugs
The dosages of the following drugs were recorded throughout the perioperative period: lidocaine, remimazolam, remifentanil, rocuronium, propofol, ephedrine, norepinephrine, atropine, esmolol, ebrantil, dyphylline, and dexamethasone.We calculated the total consumption of remimazolam and remifentanil, as well as the average consumption of remimazolam (total remimazolam consumption / duration of surgery / body weight) and the average consumption of remifentanil (total remifentanil consumption / duration of surgery / body weight).
Time frame: Perioperative period
The satisfaction of the operating physician
The operating physician rated their satisfaction with the procedure on a scale from 1 to 10. The evaluation was based on procedural convenience, oxygenation stability (specifically, whether hypoxemia necessitated interruption of the procedure), and the overall smoothness of the workflow.
Time frame: 30 minutes after surgery
Anesthesiologist satisfaction
Anesthesiologist satisfaction with the procedure was rated on a scale from 1 to 10. The evaluation was based on the difficulty of airway management (particularly the frequency of interventions required to maintain adequate ventilation), the efficacy of oxygenation maintenance, and the incidence of adverse events.
Time frame: 30 minutes after surgery
Patient satisfaction
Patients rated their satisfaction with the procedure on a scale from 1 to 10. The rating was based on procedural comfort, the postoperative recovery experience, and their subjective perception of the sedation process.
Time frame: 30 minutes after surgery
Hypotension
The incidence of systolic blood pressure less than 80% of baseline.
Time frame: Intraoperative
Hypertension
The incidence of systolic blood pressure greater than 160 mmHg, exceeding 120% of baseline, or diastolic blood pressure greater than 100 mmHg.
Time frame: Intraoperative
Bradycardia
The incidence of heart rate less than 50 beats per minute (bpm).
Time frame: Intraoperative
Tachycardia
The incidence of heart rate greater than 100 beats per minute (bpm).
Time frame: Intraoperative
Severe cough
The incidence of cough grades 2 and 3.
Time frame: Intraoperative
Severe body movement
The incidence of body movement grades 2 and 3.
Time frame: Intraoperative
Airway rescue interventions
The frequency of the following airway rescue interventions was recorded: increasing the oxygen flow rate, administering manual ventilation, administering an intravenous bolus of diprophylline (0.25 g), and administering intravenous dexamethasone (5 mg).
Time frame: Intraoperative
Peak airway pressure > 30 cmH₂O
The incidence of peak airway pressure greater than 30 cmH₂O.
Time frame: Intraoperative
Incidence of SpO₂ < 92% during bronchoscope insertion
The number of patients with SpO₂ \< 92% during bronchoscope insertion divided by the total number of patients in the group
Time frame: at the start of surgery
Shortness of breath
The number of patients who reported shortness of breath after regaining consciousness divided by the total number of patients in the group
Time frame: When the patient regained consciousness (assessed up to 30 minutes after surgery)
Procedure time
from insertion of the bronchoscope by the pulmonologist to completion of the procedure.
Time frame: Perioperative period
Anesthesia time
from the start of anesthesia induction until the patient met the discharge criteria.
Time frame: Perioperative period
Emergence time
from cessation of anesthetic infusion until the patient regained consciousness.
Time frame: Perioperative period
Recovery time
from cessation of anesthetic infusion until the patient met the discharge criteria.
Time frame: Perioperative period
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