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Disease of Respiratory SystemNCT07035301

Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures

A study testing Lidocaine Intravenous Infusion, Remimazolam Tosilate and Remifentanil in people with Disease of Respiratory System, run by Harbin Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Disease of Respiratory System
What is being tested?
Lidocaine Intravenous Infusion, Remimazolam Tosilate and Remifentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
1 siteChina
Study dates
14 Mar 2025to 14 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective electronic bronchoscopic interventional surgery;
  • Age 18 years or older;
  • American Society of Anesthesiologists (ASA) I-III;
  • The duration of bronchoscopic surgery >=20min;
  • Through pre-anesthesia assessment, the patient/family member has informed consent and signed the consent form;
  • The general clinical information of the patient is complete.

Who cannot join

  • Patients with predictable difficult airway;
  • Small mouth opening (<2 transverse fingers);
  • Combined with severe cardiovascular disease, abnormal liver and kidney function;
  • Morbidly obese patients with body mass index (BMI) greater than 35kg/m^2;
  • Has a history of gastroesophageal reflux disease.
  • High risk of reflux aspiration;
  • Those who have a history of abnormal surgical anesthesia recovery in the past;
  • Patients with mental illness and previous allergies to conventional anesthetic drugs.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

Other trials in China

About this study

Official title: Effects of Low-Dose Neuromuscular Blocking Agents on Perioperative Complications During Bronchoscopic Procedures

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?
Read more

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.
Read the 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.

Being tested
Normal Saline (Placebo), Lidocaine Intravenous Infusion, Remimazolam Tosilate, Remifentanil, Rocuronium (0.15mg/kg/body mass)
Keywords
Interventional bronchoscopy, Airway control, Remimazolam, Remifentanil, Rocuronium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal Saline (Placebo)Drug

    During anesthesia induction, an equal volume of normal saline was used instead of rocuronium for anesthesia.

  • Lidocaine Intravenous InfusionDrug

    Lidocaine was administered at a dose of 0.5mg/kg for the induction of anesthesia.

  • Remimazolam TosilateDrug

    Remimazolam was administered at a dose of 0.2 mg/kg for the induction of anesthesia.

  • RemifentanilDrug

    Remifentanil was administered at a dose of 3 micrograms per kilogram for the induction of anesthesia.

  • Rocuronium (0.15mg/kg/body mass)Drug

    Rocuronium was administered at a dose of 0.15mg/kg for the induction of anesthesia.

Study groups in NCT07035301
Study groupRoleWhat they receive
normal salinePlacebo comparatorDuring the induction of anesthesia, rocuronium is not used for anesthesia.
Receives: Drug: Normal Saline (Placebo); Drug: Lidocaine Intravenous Infusion; Drug: Remimazolam Tosilate; Drug: Remifentanil
rocuronium bromideExperimentalUsing rocuronium for anesthesia during the induction phase of anesthesia.
Receives: Drug: Lidocaine Intravenous Infusion; Drug: Remimazolam Tosilate; Drug: Remifentanil; Drug: Rocuronium (0.15mg/kg/body mass)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From initiation of anesthesia induction to completion of bronchoscope insertion

Secondary outcomes (39)
  1. 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.

    Measured: When the patient regained consciousness (assessed up to 30 minutes after surgery)

  2. Dysphagia

    After the surgery, inquire whether the patient has any difficulty in swallowing.

    Measured: When the patient regained consciousness (assessed up to 30 minutes after surgery)

  3. 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

    Measured: during anesthesia induction

  4. 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.

    Measured: At the beginning of the operation

  5. 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.

    Measured: During the process of anesthesia induction

  6. 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.

    Measured: During the process of anesthesia induction

  7. 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).

    Measured: At the beginning of the operation

  8. Nausea

    After the surgery, ask the patient if they are experiencing nausea.

    Measured: When the patient regained consciousness (assessed up to 30 minutes after surgery)

  9. Number of laryngeal mask placements

    Record the number of times the laryngeal mask is inserted when it is placed.

    Measured: During the process of anesthesia induction

  10. Vomit

    After the surgery, ask the patient if they feel like vomiting.

    Measured: When the patient regained consciousness (assessed up to 30 minutes after surgery)

  11. 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.

    Measured: During the process of anesthesia induction

  12. Bloating of stomach

    After the patient regains consciousness, ask the patient if they have any bloating in the stomach.

    Measured: When the patient regained consciousness (assessed up to 30 minutes after surgery)

  13. hoarseness

    After the patient regains consciousness, the presence of hoarseness in the patient is determined through communication with the patient.

    Measured: When the patient regained consciousness (assessed up to 30 minutes after surgery)

  14. 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.

    Measured: During the process of anesthesia induction

  15. 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).

    Measured: 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)

  16. 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.)

    Measured: 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)

  17. 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.

    Measured: 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)

  18. 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.

    Measured: 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)

  19. 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.

    Measured: 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)

  20. 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).

    Measured: 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)

  21. 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).

    Measured: 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)

  22. 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).

    Measured: Perioperative period

  23. 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.

    Measured: 30 minutes after surgery

  24. 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.

    Measured: 30 minutes after surgery

  25. 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.

    Measured: 30 minutes after surgery

  26. Hypotension

    The incidence of systolic blood pressure less than 80% of baseline.

    Measured: Intraoperative

  27. Hypertension

    The incidence of systolic blood pressure greater than 160 mmHg, exceeding 120% of baseline, or diastolic blood pressure greater than 100 mmHg.

    Measured: Intraoperative

  28. Bradycardia

    The incidence of heart rate less than 50 beats per minute (bpm).

    Measured: Intraoperative

  29. Tachycardia

    The incidence of heart rate greater than 100 beats per minute (bpm).

    Measured: Intraoperative

  30. Severe cough

    The incidence of cough grades 2 and 3.

    Measured: Intraoperative

  31. Severe body movement

    The incidence of body movement grades 2 and 3.

    Measured: Intraoperative

  32. 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).

    Measured: Intraoperative

  33. Peak airway pressure > 30 cmH₂O

    The incidence of peak airway pressure greater than 30 cmH₂O.

    Measured: Intraoperative

  34. 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

    Measured: at the start of surgery

  35. 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

    Measured: When the patient regained consciousness (assessed up to 30 minutes after surgery)

  36. Procedure time

    from insertion of the bronchoscope by the pulmonologist to completion of the procedure.

    Measured: Perioperative period

  37. Anesthesia time

    from the start of anesthesia induction until the patient met the discharge criteria.

    Measured: Perioperative period

  38. Emergence time

    from cessation of anesthetic infusion until the patient regained consciousness.

    Measured: Perioperative period

  39. Recovery time

    from cessation of anesthetic infusion until the patient met the discharge criteria.

    Measured: Perioperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start14 Mar 2025
  3. Primary completion30 Jun 2026
  4. Study completion14 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035301
Sponsor's protocol ID
ChiCTR2500098978
Status last verified
Oct 2026
First submitted
12 May 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The original data sharing platform (IPD sharing platform) of ResMan, a clinical trial registration center of China, on June 30, 2028.

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine Intravenous Infusion, Remimazolam Tosilate and Remifentanil in people with Disease of Respiratory System, run by Harbin Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence rate of laryngeal spasm (time frame: From initiation of anesthesia induction to completion of bronchoscope insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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