Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures

Not Applicable

Recruiting

• Conditions: Disease of Respiratory System
• Interventions: Drug: Normal Saline (Placebo); Drug: Lidocaine Intravenous Infusion; Drug: Remimazolam Tosilate; Drug: Remifentanil; Drug: Rocuronium (0.15mg/kg/body mass)

• Registration Number: NCT07035301
• Lead Sponsor: Harbin Medical University

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

Patients scheduled for endoscopic interventional surgery were randomly divided into two groups: Group A (without muscle relaxation) and Group B (with muscle relaxation). Group A (intravenous administration of lidocaine 0.5mg/kg, remimazolam 0.2mg/kg, and remifentanil 3ug/kg); Group B (intravenous administration of lidocaine 0.5mg/kg, remimazolam 0.2mg/kg, remifentanil 3ug/kg, and rocuronium 0.15mg/kg). The total air flow rate was 6L/min, with oxygen-air ratio of 1:1. Both groups used standard techniques to insert the appropriate-sized laryngeal mask. The muscle rigidity grade after anesthesia induction, the satisfaction of laryngeal mask insertion, the incidence of laryngeal spasm, the grading of intraoperative cough, and the recovery of patients after surgery were recorded.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-03-17
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-06
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	Normal Saline (Placebo)	During the induction of anesthesia, rocuronium is not used for anesthesia.
normal saline	Remimazolam Tosilate	During the induction of anesthesia, rocuronium is not used for anesthesia.
normal saline	Lidocaine Intravenous Infusion	During the induction of anesthesia, rocuronium is not used for anesthesia.
normal saline	Remifentanil	During the induction of anesthesia, rocuronium is not used for anesthesia.
rocuronium bromide	Rocuronium (0.15mg/kg/body mass)	Using rocuronium for anesthesia during the induction phase of anesthesia.
rocuronium bromide	Lidocaine Intravenous Infusion	Using rocuronium for anesthesia during the induction phase of anesthesia.
rocuronium bromide	Remimazolam Tosilate	Using rocuronium for anesthesia during the induction phase of anesthesia.
rocuronium bromide	Remifentanil	Using rocuronium for anesthesia during the induction phase of anesthesia.

Primary Outcome Measures

Name	Time	Method
The incidence rate of laryngeal spasm	At the beginning of the operation	Observe the degree of glottic opening (grade 0: glottis opens well; grade 1: glottis opens ≥⅔, mild laryngospasm; grade 2: glottis opens ⅓-⅔, moderate laryngospasm; grade 3: glottis opens ≤⅓ or is completely closed, severe laryngospasm).
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; grade 3: severe choking cough response.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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).
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).
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.
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).
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	Record the time from the start of laryngeal mask insertion to the completion of laryngeal mask insertion.

Trial Locations

Locations (1)

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China