Disease of Respiratory System
Conditions
Keywords
Interventional bronchoscopy, Airway control, Remimazolam, Remifentanil, Rocuronium
Brief summary
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.
Detailed description
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.
Interventions
DRUGNormal Saline (Placebo)
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.
DRUGRemifentanil
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.
Sponsors
Harbin Medical University
First Affiliated Hospital of Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing elective electronic bronchoscopic interventional surgery; 2. Age 18 years or older; 3. American Society of Anesthesiologists (ASA) I-III; 4. The duration of bronchoscopic surgery \>=20min; 5. Through pre-anesthesia assessment, the patient/family member has informed consent and signed the consent form; 6. The general clinical information of the patient is complete.
Exclusion criteria
1. Patients with predictable difficult airway; 2. Small mouth opening (\<2 transverse fingers); 3. Combined with severe cardiovascular disease, abnormal liver and kidney function; 4. Morbidly obese patients with body mass index (BMI) greater than 35kg/m\^2; 5. Has a history of gastroesophageal reflux disease. 6. High risk of reflux aspiration; 7. Those who have a history of abnormal surgical anesthesia recovery in the past; 8. Patients with mental illness and previous allergies to conventional anesthetic drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence rate of laryngeal spasm | At the beginning of the operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The severity of postoperative sore throat | When 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. |
| Dysphagia | When the patient regained consciousness (assessed up to 30 minutes after surgery) | After the surgery, inquire whether the patient has any difficulty in swallowing. |
| The incidence of oxygen desaturation (SpO₂ < 92%) during mask ventilation | during anesthesia induction | The number of patients with SpO₂ \< 92% during mask ventilation in the induction period / total number of patients in the group |
| Grading of body movement during bronchoscope insertion | At 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. |
| Grading of chest wall rigidity | During 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. |
| Difficult facemask ventilation | During 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. |
| The incidence rate of choking cough when the bronchoscope first enters the trachea | At the beginning of the operation | 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). |
| Nausea | When the patient regained consciousness (assessed up to 30 minutes after surgery) | After the surgery, ask the patient if they are experiencing nausea. |
| Number of laryngeal mask placements | During the process of anesthesia induction | Record the number of times the laryngeal mask is inserted when it is placed. |
| Vomit | When the patient regained consciousness (assessed up to 30 minutes after surgery) | After the surgery, ask the patient if they feel like vomiting. |
| Is 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. |
| Bloating of stomach | When 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. |
| hoarseness | When 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. |
| Time of laryngeal mask placement | During 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. |
| blood pressure | 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) | 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). |
| heart rate | 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: 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.) |
| oxyhemoglobin saturation | 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) | 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. |
| Bispectral index | 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) | 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. |
| airway peak pressure | 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 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. |
| Airway platform pressure | 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 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). |
| Carbon dioxide at the end of breathing | 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) | 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). |
| Dosage of Anesthetic Drugs | Perioperative period | 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). |
| The satisfaction of the operating physician | 30 minutes after surgery | 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. |
| Anesthesiologist satisfaction | 30 minutes after surgery | 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. |
| Patient satisfaction | 30 minutes after surgery | 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. |
| Hypotension | Intraoperative | The incidence of systolic blood pressure less than 80% of baseline. |
| Hypertension | Intraoperative | The incidence of systolic blood pressure greater than 160 mmHg, exceeding 120% of baseline, or diastolic blood pressure greater than 100 mmHg. |
| Bradycardia | Intraoperative | The incidence of heart rate less than 50 beats per minute (bpm). |
| Tachycardia | Intraoperative | The incidence of heart rate greater than 100 beats per minute (bpm). |
| Severe cough | Intraoperative | The incidence of cough grades 2 and 3. |
| Severe body movement | Intraoperative | The incidence of body movement grades 2 and 3. |
| Airway rescue interventions | Intraoperative | 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). |
| Peak airway pressure > 30 cmH₂O | Intraoperative | The incidence of peak airway pressure greater than 30 cmH₂O. |
| Incidence of SpO₂ < 92% during bronchoscope insertion | at the start of surgery | The number of patients with SpO₂ \< 92% during bronchoscope insertion divided by the total number of patients in the group |
| Shortness of breath | When the patient regained consciousness (assessed up to 30 minutes after surgery) | The number of patients who reported shortness of breath after regaining consciousness divided by the total number of patients in the group |
| Procedure time | Perioperative period | from insertion of the bronchoscope by the pulmonologist to completion of the procedure. |
| Anesthesia time | Perioperative period | from the start of anesthesia induction until the patient met the discharge criteria. |
| Emergence time | Perioperative period | from cessation of anesthetic infusion until the patient regained consciousness. |
| Recovery time | Perioperative period | from cessation of anesthetic infusion until the patient met the discharge criteria. |
Countries
China
Contacts
STUDY_DIRECTORSHI Jinghui SHI
Outcome results
None listed